October 31, 2019 at 08:06PM Westlake IVF, LLC - 590113 - 09/30/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

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October 31, 2019 at 07:36PM Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products

Draft Guidance

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October 31, 2019 at 05:11PM Procleix Zika Virus Assay

The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid test for the detection of Zika virus (ZIKV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, for transfusion. It is also intended for use in testing plasma or serum specimens to screen other living (heart-beating) donors of organs and Human Cells, Tissues, and Cellular and Tissue-Based Procucts (HCT/Ps), and in testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens. The assay is intended for use in testing individual donor samples. It is also intended for use in testing pools of human plasma composed of equal aliquots of not more than 16 individual specimens from volunteer donors of whole blood components. This assay is not intended for use as an aid in diagnosis of Zika virus infection.

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October 31, 2019 at 03:53PM What to Ask Your Doctor Before Taking Opioids

Opioids can be used to treat certain kinds of chronic and acute pain. It doesn't matter who is writing the prescription; ask these questions before taking opioids.

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October 31, 2019 at 03:12PM Section 8000: General Information

This is the main page for CBER's SOPP Section 8000: General Information.

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October 30, 2019 at 02:10PM Application Submissions Guidances

This page lists Application Submissions Guidance documents.

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October 29, 2019 at 08:57PM Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Announcement - 11/08/2019 - 11/08/2019

This is the CBER Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Announcement.

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October 29, 2019 at 06:39PM CBER-Regulated Products: Shortages and Discontinuations

A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand.

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October 29, 2019 at 03:48PM Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding bloo

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October 29, 2019 at 03:41PM Hizentra

Product approval information is indicated for treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.

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October 29, 2019 at 03:24PM Gamunex-C

For use in primary humoral immunodeficiency, idiopathic thrombocytopenic purpura and chronic inflammatory demyelinating polyneuropathy.

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October 29, 2019 at 03:17PM Consumer Updates

Get timely, reliable, health and safety information about food, drugs, medical devices, vaccines, pet food, pet medicine and more.

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October 29, 2019 at 02:53PM Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

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October 29, 2019 at 02:37PM Combating Antibiotic Resistance

Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics

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October 29, 2019 at 02:37PM Combating Antibiotic Resistance

Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics

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October 28, 2019 at 05:19PM Men With Breast Cancer Need More Treatment Options and Access to Genetic Counseling

Breast cancer in men tends to be diagnosed at an older age and when the cancer is at a later stage, but is treated very similarly to breast cancer in women. The FDA encourages the inclusion of men in breast cancer clinical trials.

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October 29, 2019 at 11:26AM Gammaplex 5% & 10%

Gammaplex 5%: For the treatment of (1) primary humoral immunodeficiency (PI) in adults and pediatric patients two years of age and older; (2) chronic immune thrombocytopenic purpura (ITP)

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October 28, 2019 at 08:59PM Acceptance of Foreign Clinical Studies Information Sheet

Acceptance of Foreign Clinical Studies - Info Sheet

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October 28, 2019 at 08:36PM Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols

This is the Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols.

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October 28, 2019 at 08:33PM Withdrawn - Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research; Draft Guidance for Industry

Guidance for Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research.

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October 28, 2019 at 05:40PM Emergency Use Authorization

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies

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October 25, 2019 at 06:07PM Annual Meeting of the American Association for the Advancement of Science

With the participation of CIRAD.

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October 28, 2019 at 10:17AM The first global earthworm map reveals substantial diversity that is now under threat from climate change

Global climate change could impact on earthworm communities worldwide, threatening the many functions they provide. This is one of the results of the first operation to map earthworm populations on a global scale, published in Science on 25 October. The work* involved 140 researchers worldwide, including a specialist from CIRAD, who compiled the largest ever dataset on earthworms, covering almost 7000 sites in 57 countries.

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October 28, 2019 at 12:50PM New Drug Applications with Supporting Documents

List including applications in alphabetical order by product name for which have approval documents available, and reflects the information as of the approval date.

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October 24, 2019 at 04:33PM What’s driving tropical deforestation? Scientists map 45 years of satellite images

A new mapping method that built upon data from over 45 years could help pinpoint what is driving tropical deforestation and where forests are most vulnerable to future degradation and fires. The method has been used for the first time in Vietnam.

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October 28, 2019 at 10:17AM La première cartographie mondiale des vers de terre révèle une biodiversité insoupçonnée, menacée par le changement climatique

Les changements climatiques mondiaux pourraient bouleverser les communautés de vers de terre à travers le monde, mettant en péril les nombreuses fonctions qu’ils remplissent. C’est l’un des résultats de la première cartographie des vers de terre menée à l’échelle mondiale et publiée à la Une de Science le 25 octobre. Ces travaux* ont réuni 140 chercheurs internationaux, dont un spécialiste du Cirad, pour compiler le plus grand ensemble de données sur les vers de terre, comprenant près de 7000 sites dans 57 pays.

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October 25, 2019 at 10:35PM Licensed Biological Products with Supporting Documents

Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

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October 25, 2019 at 08:01PM Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies - 11/04/2019 - 11/04/2019

The purpose of the public hearing is to obtain public input on the state of the science regarding FMT to treat C. difficile infection not responsive to standard therapies, including the available clinical evidence for safety and effectiveness of FMT for this use and to better understand the impact of FDA’s enforcement policy on product development.

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October 25, 2019 at 06:07PM Colloque annuel de l'American Association for the Advancement of Science

Avec la participation du Cirad.

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October 25, 2019 at 06:17PM Flebogamma DIF 5% & 10%

Product approval information is indicated for:
•Flebogamma 5% DIF: Treatment of primary (inherited) immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.
•Flebogamma 10% DIF: Treatment of (1) primary (inherited) immunodeficiency; (2) chronic primary immune thrombocytopenia (ITP) in patients 2 years of age and older.

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October 25, 2019 at 05:12PM Patient Listening Sessions

Patient Listening Sessions led by FDA’s Patient Affairs Staff provide an opportunity for medical product Centers to engage with patients, caregivers, and their advocates about their experience with a disease or condition.

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October 25, 2019 at 03:27PM Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry

Guidance for Industry: Clinical/Medical

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October 25, 2019 at 03:23PM Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry

Guidance for Industry - Labeling

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October 25, 2019 at 03:19PM Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry

Guidance for Industry: Labeling

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October 25, 2019 at 03:08PM MP Diagnostics HTLV Blot 2.4

Product approval information for detection of antibodies to HTLV-I (anti-HTLV-I) and/ or antibodies to HTLV-II (anti-HTLV-II) in human serum and plasma specimens.

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October 21, 2019 at 04:02PM Open science for global science, a collective challenge in both North and South

Giving open access to research results is a laudable goal in a world of strong competition in the research sector, as in teaching and innovation. What are the advantages? How can we overcome the obstacles? These questions will be at the heart of the first symposium on open science in the global South, organized by CIRAD, IRD and Cheikh Anta Diop University (UCAD) in Dakar, Senegal, from 23 to 25 October 2019. CIRAD committed to open science as far back as 2006, in signing the Berlin Declaration. Marie-Claude Deboin, Head of Scientific and Technical Information at CIRAD, explains the collective challenge posed by this issue in both North and South.

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October 25, 2019 at 02:44PM Cervarix

Prevention of cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and cervical intraepithelial neoplasia (CIN) grade 1, caused by oncogenic human papillomavirus (HPV) types 16 and 18, in females9 through 25 years of age.

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October 25, 2019 at 02:04PM Clinical Guidances

This page lists Clinical Guidance documents.

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October 25, 2019 at 02:00PM MCM-Related Counterterrorism Legislation

Since September 11, 2001, federal legislation has been enacted to strengthen the nation’s preparedness for responding to public health emergencies involving chemical, biological, radiological, nuclear (CBRN) as well as emerging infectious disease threats.

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October 24, 2019 at 08:31PM BEXSERO

Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

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October 24, 2019 at 08:18PM Population Pharmacokinetics

Clinical Pharmacology

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October 24, 2019 at 08:03PM Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry

Clinical/Medical

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October 24, 2019 at 07:35PM Gardasil

Product approval information for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant also known as Gardasil.

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October 24, 2019 at 07:19PM December 10, 2014 Approval Letter -GARDASIL 9

Human Papillomavirus 9-valent Vaccine, Recombinant

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October 24, 2019 at 06:07PM Gardasil 9

Product approval information for Human Papillomavirus 9-valent Vaccine, Recombinant also known as Gardasil 9.

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October 24, 2019 at 06:07PM FDA Voices on Medical Products

FDA Voices on Medical Products

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October 24, 2019 at 04:33PM Un nouvel outil pour identifier les causes de la déforestation tropicale

Une nouvelle méthode de cartographie construite à partir de 45 ans d’images satellite pourrait aider à identifier les causes de la déforestation tropicale et les endroits où les forêts sont les plus vulnérables à la dégradation et aux incendies futurs. La méthode a été utilisée pour la première fois au Vietnam.

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October 23, 2019 at 05:21PM Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry

Clinical /Medical

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October 21, 2019 at 06:20PM What to Know About Breast Implants

The U.S. Food and Drug Administration regulates breast implants as medical devices. Learn about the risks of these products, and consider this advice.

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October 22, 2019 at 05:52PM Influenza Virus Vaccine, Quadrivalent, Types A and Types B

List of Influenza Virus Vaccine, Quadrivalent, Types A and Types B

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October 22, 2019 at 04:47PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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October 22, 2019 at 04:01PM Influenza Virus Vaccine, Trivalent, Types A and B

List of Influenza Virus Vaccine, Trivalent, Types A and B products

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October 22, 2019 at 03:54PM Dr Sharpless's remarks to the 2019 NORD Conference on Rare Diseases - 10/22/2019

Remarks by Acting Commissioner Ned Sharpless, 2019 NORD Conference on Rare Diseases, Oct 22, 2019, Washington, DC

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October 22, 2019 at 03:18PM FDA scientists discover key chemical steps in formation of microparticles carrying abnormal hemoglobin in sickle cell disease

Summary of scientific article by Abdu Alayash on SCD/Hb/hydroxyurea

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October 21, 2019 at 08:51PM Good Dog, Bad Food: Foods for People That Are Bad for Your Dog

Some foods that are meant for people can be dangerous, and even deadly, to your dog.

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October 21, 2019 at 03:49PM 4th International Conference on Animal Health Surveillance (ICAHS 4)

Organisé la Danish Veterinary and Food Administration, le Danish Agriculture & Food Council, la Technical University of Denmark, avec la participation du Cirad.

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October 21, 2019 at 04:02PM Une science ouverte pour une science mondiale, un enjeu collectif au Sud comme au Nord

Donner libre accès aux résultats de recherche : une démarche louable dans un monde où la compétition est à l’œuvre dans la recherche comme dans l’enseignement et pour l’innovation. Quel en est l’intérêt ? Comment lever les freins ? Des questions qui seront au cœur du 1er colloque « Science ouverte au Sud » organisé par le Cirad, l’IRD et l’Université Cheikh Anta Diop (UCAD) à Dakar, Sénégal du 23 au 25 octobre 2019. Alors que le Cirad est engagé pour une science ouverte depuis 2006 avec la signature de la déclaration de Berlin, Marie-Claude Deboin, déléguée à l’Information scientifique et technique au Cirad, précise l’enjeu collectif de cette démarche au Sud comme au Nord.

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October 17, 2019 at 02:32PM Dakar hosts the first international symposium on open science in the global South

IRD, CIRAD and Cheikh Anta Diop University (UCAD) are organizing the first international symposium on open science in the global South from 23 to 25 October at UCAD's Institut Confucius in Dakar (Senegal). A large number of players – researchers, scientific information professionals, representatives of research organizations – will be discussing the issues surrounding open science in the global South.

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October 21, 2019 at 03:13PM Roster of the Blood Products Advisory Committee

This is the Roster of the Blood Products Advisory Committee (BPAC).

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October 21, 2019 at 02:31PM Clinical Investigator Status (Biologics)

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

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October 21, 2019 at 02:28PM Clinical Investigator Inspection List A-D

Contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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October 21, 2019 at 02:27PM Clinical Investigator Inspection List E-K

Contains names, addresses, and other information gathered from inspections of clinical investigators (E-K) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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October 21, 2019 at 02:25PM Clinical Investigator Inspection List L-P

Contains names, addresses, and other information gathered from inspections of clinical investigators (L-P) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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October 21, 2019 at 02:22PM Clinical Investigator Inspection List T-Z

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

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October 21, 2019 at 01:36PM MCM-Related Guidance by Date

Guidances and other information of special interest to MCM stakeholders, sponsors and applicants, listed by date

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October 21, 2019 at 01:35PM Guidance and Other Information of Special Interest to MCM Stakeholders

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

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October 17, 2019 at 08:31PM Considerations When Transferring Clinical Investigation Oversight to Another IRB

Draft Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB

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October 17, 2019 at 08:22PM Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

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October 17, 2019 at 06:03PM Expanding Criminal Enforcement Operations Globally to Protect Public Health

FDA’s inspections, investigations, and law enforcement operations are led by the Office of Regulatory Affairs and the Office of Criminal Investigations’s law enforcement investigators are critical to protecting public health

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October 17, 2019 at 05:41PM New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products

Guidance for industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products

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October 17, 2019 at 05:39PM Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

Clinical/Medical

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October 17, 2019 at 05:24PM Fast Track Designation Request Performance

The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling submission" for a marketing application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.

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October 17, 2019 at 05:22PM Section 8500: Compliance

This is the SOPP Section 8500: Compliance main page.

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October 17, 2019 at 05:12PM Male Breast Cancer: Developing Drugs for Treatment

Draft guidance for industry: Male Breast Cancer: Developing Drugs for Treatment.

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October 17, 2019 at 02:32PM Dakar accueille le premier colloque international "Science ouverte au Sud"

L’IRD, le Cirad et l’Université Cheikh Anta Diop (UCAD) organisent le 1er colloque international « Science ouverte au Sud » du 23 au 25 octobre à l’Institut Confucius de l’UCAD à Dakar (Sénégal). De nombreux acteurs – chercheurs, professionnels de l’information scientifique, représentants d’institutions de recherche – discuteront des enjeux de la science ouverte dans les pays du Sud.

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October 16, 2019 at 09:30PM Cleared 510(k) Submissions with Supporting Documents - 2019

List of Cleared 510(k) Submissions with Supporting Documents for 2019

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October 16, 2019 at 08:37PM JYNNEOS

Indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.


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October 16, 2019 at 07:00PM Jobs at the Center for Biologics Evaluation and Research (CBER)

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

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October 16, 2019 at 05:55PM Focusing on Contact Lens Safety

In addition to offering flexibility and convenience, contacts help correct a variety of vision disorders. But contact lenses also present potential risks. See these safety basics, including information on proper hygiene and proper practices for cleaning, disinfecting, and storing your lenses.

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October 16, 2019 at 05:35PM Vaccine and Related Biological Product Guidances

This page contains a listing of vaccine and related biological product guidances

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October 16, 2019 at 03:32PM What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding

FDA strongly advises against the use of cannabidiol (CBD), tetrahydrocannabinol (THC), and marijuana in any form during pregnancy or while breastfeeding.


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October 16, 2019 at 02:55PM Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry

User Fees

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October 16, 2019 at 12:20PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.

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October 15, 2019 at 10:55PM Allergenics

Lists three types of allergenic products licensed for use: allergen extracts, allergen patch tests, and antigen skin tests. Allergen extracts are used for the diagnosis and/or treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. Allergen patch tests are diagnostic tests applied to the surface of the skin. Antigen skin tests are diagnostic tests injected into the skin to aid in the diagnosis of infection with certain pathogens.

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October 15, 2019 at 08:52PM November 7, 2017: Vaccines and Related Biological Products Advisory Committee Meeting Announcement - 11/07/2017 - 11/07/2017

This is the Meeting Announcement for the November 7, 2017, Vaccines and Related Biological Products Advisory Committee Meeting

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October 15, 2019 at 03:20PM Westlake IVF, LLC - 590113 - 09/30/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

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October 15, 2019 at 12:55PM Rare Pediatric Disease Priority Review Vouchers

Draft guidance for industry on rare pediatric disease priority review vouchers, revised July 2019

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October 15, 2019 at 11:02AM A new report reveals the threats to food systems

Food systems are currently under an unprecedented number of threats. This is the alarming conclusion drawn by more than fifty CIRAD researchers in a report on the trends and challenges for food systems co-published by FAO, the European Commission and CIRAD. The conclusions of the report have just been presented in Rome at the request of the Global Network against Food Crises, at the 46th meeting of the Committee on World Food Security.

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October 15, 2019 at 11:02AM Un nouveau rapport lève le voile sur les menaces pesant sur les systèmes alimentaires

L’accumulation des risques qui pèsent sur les systèmes alimentaires est inédite. C’est le constat alarmant de plus de cinquante chercheurs du Cirad, dans un rapport sur les tendances et les défis des systèmes alimentaires, co-édité par la FAO, la Commission européenne et le Cirad. Les conclusions de ce rapport viennent d’être présentées à Rome à l’invitation du réseau mondial contre les crises alimentaires (High Level Event of the Global Network against Food Crises) à l’occasion de la 46ème réunion du Comité de la sécurité alimentaire mondiale.

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October 11, 2019 at 09:56PM Resources for You (Biologics)

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

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October 11, 2019 at 08:51PM Regenerative Medicine Advanced Therapy Designation

Eligibility requirements for a regenerative medicine advanced therapy (RMAT) designation. Information on when and where to submit the request is also provided.

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October 11, 2019 at 08:13PM FDA’s Forensic Chemistry Center Playing Critical Role in Vaping Illness Investigation

FDA’s Forensic Chemistry Center serves as the agency’s premier national forensic laboratory for research and analyses related to criminal and regulatory investigations involving FDA-regulated products.

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October 11, 2019 at 08:01PM Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review; Public Workshop - 07/15/2019 - 07/16/2019

The purpose of this workshop is to provide an overview of key elements of regulatory submissions for these devices, and to facilitate education and communication between manufacturers and sponsors of these devices and the divisions in CBER that regulate them.

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October 09, 2019 at 12:51PM Urbal, or how to pinpoint the impacts of innovations on food system sustainability

Twelve food innovations in ten cities worldwide are are currently the object of close scrutiny via a participatory methodology for assessing sustainability. The aim of the Urbal project, coordinated by CIRAD*, is to provide project leaders, donors and decision-makers with a lightweight, open-source method for characterizing the impacts of innovations on food system sustainability. The results of initial tests of the method, on three food innovations developed in Brasilia, Rabat and Montpellier, are promising. They were due to serve as examples on 10 October at a round table on the last day of the meeting of mayors of signatory cities to the Milan Pact, in Montpellier.

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Vaping Illnesses Climb Upward, Nearing 1,300 With 27 Deaths - The New York Times

1. Vaping Illnesses Climb Upward, Nearing 1,300 With 27 Deaths  The New York Times
2. More than two dozen now dead from vaping lung illness as outbreak spreads, CDC says  CNBC
3. U.S. vaping-related deaths rise to 26, illnesses to 1,299  Yahoo News
4. US vaping illnesses rise to nearly 1,300, cause still a mystery  The Boston Globe
5. Vaping Illness Cases Continue To Climb In Florida  CBS Miami
6. View full coverage on Google News

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October 10, 2019 at 09:07PM Section 8200: Investigational New Drugs (INDs)

This is the SOPP Section 8200: Investigational New Drugs (INDs) main page.

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October 10, 2019 at 04:10PM Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review

Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review, Guidance for Industry, Technical Specifications Document, OVRR, CBER, Biologics, Application Submissions Guidance, Vaccine and Related Biological Product Guidance, Study Data Standards Resources Guidance

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October 10, 2019 at 02:30PM Innovation and Regulatory Science

Innovation and Regulatory Science

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October 10, 2019 at 01:49PM Influenza candidate vaccine viruses improved by amino acid substitution in hemagglutinin

Scientists at the U.S. Food and Drug Administration (FDA) developed two candidate vaccine viruses (CVVs) that may be used as the starting material for production of inactivated influenza vaccines. These CVVs protected laboratory animals against a highly pathogenic strain of Influenza A (H7N9), a pot

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October 10, 2019 at 01:50PM Sécurité alimentaire mondiale : GloFoodS dévoile ses résultats

GloFoodS prend part aux recherches mondiales sur la sécurité alimentaire et nutritionnelle. Le métaprogramme mobilise les forces scientifiques de l’Inra et du Cirad depuis cinq ans sur ce défi pressant. Après deux appels à manifestation d’intérêt, les résultats de la première vague de projets sont disponibles sous forme de fiches de synthèse. Celles-ci illustrent la diversité des approches et des problématiques des travaux soutenus par GloFoodS.

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October 09, 2019 at 05:10PM Help the FDA Prevent Kids from Using Tobacco

The U.S. Food and Drug Administration needs your help to ensure that communities nationwide are following federal tobacco laws. Here's how you can report potential violations.

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October 09, 2019 at 04:45PM Help The FDA Keep Kids from Using Tobacco

The U.S. Food and Drug Administration needs your help to ensure that communities nationwide are following federal tobacco laws. Here's how you can report potential violations.

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October 09, 2019 at 02:51PM Section 8000: General Information

This is the main page for CBER's SOPP Section 8000: General Information.

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October 09, 2019 at 01:55PM Emergency Use Authorization

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies

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October 09, 2019 at 12:51PM Urbal ou comment identifier les impacts d’une innovation sur la durabilité des systèmes alimentaires

Douze innovations alimentaires dans dix villes du monde sont actuellement passées au crible d’une méthodologie participative d’évaluation de la durabilité. Objectif de ce projet, nommé Urbal, coordonné par le Cirad* : fournir aux porteurs de projet, aux bailleurs et aux décideurs une méthode légère et open-source pour caractériser les impacts des innovations sur la durabilité des systèmes alimentaires. Les premiers tests de la méthode, sur trois innovations alimentaires nées à Brasilia, Rabat et Montpellier, sont prometteurs. Ils serviront d’exemples le 10 octobre lors d’une table ronde organisée en clôture de la réunion des maires du Pacte de Milan à Montpellier

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October 07, 2019 at 03:16PM Antananarivo | How green is my city

From the air, the Madagascan capital looks remarkably green, despite its three million inhabitants. This is because almost half its land area is given over to farming, and one in every five households is at least partly involved in producing food. This new information comes from the Légende project, coordinated by CIRAD, and is very precious, at a time when the future urban development plan for the city is under discussion. Antananarivo would well serve as an example at the 5th Milan Pact Summit, which began on 7 October in Montpellier.

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October 08, 2019 at 04:25PM Global Commodities Corporation Recalls Buenas Grated Coconut Due to Possible Health Risk-Biologics

Global Commodities Corporation, Hayward, CA is recalling one lot of Buenas Brand frozen grated coconut because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with we

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October 08, 2019 at 03:22PM Family Fertility Center - 588805 - 09/30/2019

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)


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October 07, 2019 at 09:10PM Devices Guidances

This page lists Medical Device Guidance documents.

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October 07, 2019 at 04:55PM CBER Vaccine ICSR Implementation

The CBER ICSR Implementation webpage was created to provide current information about CBER’s progress toward the adoption and implementation of the ISO/HL7 Individual Case Safety Report (ICSR) standard and the ICH E2B(R3) revised content specification to support electronic reporting to the Vaccine Adverse Event Reporting System (VAERS)

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October 07, 2019 at 03:16PM Antananarivo, ville cultivée

Vue du ciel, la capitale de Madagascar est singulièrement verte malgré ses 3 millions d’habitants. Et pour cause, presque la moitié de sa surface est dédiée à l’agriculture et 1 ménage sur 5 consacre une partie de son activité à la production alimentaire. Ces connaissances inédites résultent du projet Légende coordonné par le Cirad. Elles offrent des informations précieuses au moment où se discute le futur plan d’aménagement de la ville. Antananarivo pourrait bien faire figure d’exemple au 5e sommet annuel du Pacte de Milan qui démarre aujourd’hui à Montpellier.

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October 04, 2019 at 07:20PM Vaping Illness Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street

The FDA is strengthening its warning to consumers to stop using vaping products containing THC and any vaping product obtained off the street amid more than 1,000 reports of lung injuries—including some resulting in deaths—following the use of vaping products.

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October 04, 2019 at 06:55PM cobas TaqScreen MPX Test, version 2.0 for use with the cobas s 201 system

Product approval information for
•Direct detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA, and Hepatitis B Virus (HBV) DNA in human plasma.
•Simultaneous detection and discrimination of HIV RNA, HCV RNA, and HBV DNA.

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October 04, 2019 at 05:45PM 2019 Meeting Materials, Blood Products Advisory Committee

This is the main page for CBER 2019 Meeting Materials, Blood Products Advisory Committee.

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October 04, 2019 at 05:43PM Blood Products Advisory Committee November 22, 2019 Meeting Announcement - 11/22/2019 - 11/22/2019

This is the CBER Blood Products Advisory Committee November 22, 2019 Meeting Announcement.

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October 04, 2019 at 04:50PM APTIMA HIV-1 RNA Qualitative Assay

Product approval information is indicated for use as an aid in diagnosis of HIV-1 infection, including acute or primary infection.

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October 04, 2019 at 04:15PM HPC, Cord Blood - Bloodworks

The approval letter for Bloodworks Biologics License Application for HPC, Cord Blood - BLA 125585 is indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

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Vaping illnesses top 1,000, an increase of 275 cases, CDC says - NBC News

1. Vaping illnesses top 1,000, an increase of 275 cases, CDC says  NBC News
2. Vaping illness outbreak surpasses 1,000 cases, 18 deaths with no sign of slowing, CDC says  CNBC
3. Vaping Illness Case Count Tops 1,000, With 18 Deaths : Shots - Health News  NPR
4. Vaping lung injuries top 1,000 cases as deaths rise to 18  The Washington Post
5. US vaping illness deaths rise to 18 with 1,000 cases reported  BBC News
6. View full coverage on Google News

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Vaping Illness Case Count Tops 1,000, With 18 Deaths : Shots - Health News - NPR

1. Vaping Illness Case Count Tops 1,000, With 18 Deaths : Shots - Health News  NPR
2. Vaping illness outbreak surpasses 1,000 cases, 18 deaths with no sign of slowing, CDC says  CNBC
3. Vaping lung injuries top 1,000 cases as deaths rise to 18  Washington Post
4. 18 Americans have died of vaping illness as cases surge past 1,000, CDC reports  Daily Mail
5. What you need to know about the deadly lung illnesses tied to vaping  Los Angeles Times
6. View full coverage on Google News

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October 03, 2019 at 10:05PM Health Fraud Scams

Learn how to spot health fraud and avoid it.

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October 03, 2019 at 09:10PM FDA Voices on Policy

FDA Voices on Policy

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October 03, 2019 at 09:00PM FDA Voices: Perspectives From FDA Leadership and Experts

Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement.

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October 03, 2019 at 08:30PM CLEVECORD (HPC Cord Blood)

CLEVECORD, HPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment

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October 03, 2019 at 08:15PM ENGERIX-B

ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

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October 03, 2019 at 07:40PM HAVRIX

For active immunization against disease caused by hepatitis A virus (HAV) for persons 12 months of age and older.

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October 03, 2019 at 07:25PM TWINRIX

Active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus

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October 03, 2019 at 07:00PM HIBERIX

HIBERIX is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b.

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October 03, 2019 at 06:35PM TachoSil

Product approval information is indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

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October 03, 2019 at 06:21PM Consumer Updates

Get timely, reliable, health and safety information about food, drugs, medical devices, vaccines, pet food, pet medicine and more.

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October 03, 2019 at 03:52PM Making Sure Kids Are Prepared if They Need Epinephrine Treatments in School

Kids are back in school, which for many parents, means making sure important prescriptions, like epinephrine products, are filled and available to use when necessary. FDA wants to make sure patients, parents, health care providers, school nurses, and pharmacists stay on top of product availability.

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October 03, 2019 at 04:46PM The FDA’s Critical Focus on Women’s Health

The FDA takes very seriously its long-standing commitment and involvement in medical science and growth in our overall understanding of, and approach to, women’s health.

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October 03, 2019 at 04:22PM EVARREST (Fibrin Sealant Patch)

Product approval information is indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

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October 03, 2019 at 03:45PM RAPLIXA

Product approval information is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

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October 03, 2019 at 02:55PM MedWatch Safety Alerts for Human Medical Products

MedWatch alerts provide timely, actionable safety information on human drugs, medical devices, biologics, dietary supplements, and cosmetics.

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October 03, 2019 at 11:24AM Recurring fires in Indonesia: how might we break the vicious circle?

For a month now, Indonesia has been shrouded in a dense cloud of smoke caused by gigantic fires. That smoke has been carried by the prevailing winds and is now crossing the country's borders. We look into the underlying causes of the smoke and fires.

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October 03, 2019 at 11:24AM Incendies récurrents en Indonésie : briser le cercle vicieux

L’Indonésie est plongée depuis un mois dans un immense nuage de fumée causé par des feux géants. Des fumées portées par les vents dominants et qui franchissent les frontières. Décryptage sur les causes profondes de l’origine des fumées et des feux.

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October 02, 2019 at 11:51PM Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration

FDA/CBER - Draft Guidance for Industry: Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration

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October 02, 2019 at 08:45PM Quadracel

Indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series

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October 02, 2019 at 08:00PM Kinrix

Changes to your package insert to the Dosage and Administration section regarding visual inspection by the user for cracked vials or syringes prior to administration of the vaccine and non-use of product should those conditions exist.

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October 02, 2019 at 07:50PM Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

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October 02, 2019 at 07:40PM Daptacel

Indicated for active immunization against diphtheria, tetanus and pertussis as a five dose series in infants and children 6 weeks through 6 years of age (prior to 7th birthday).

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October 02, 2019 at 07:15PM ANAVIP

Product approval information is indicated for the management of adult and pediatric patients with North American rattlesnake envenomation.

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October 02, 2019 at 06:49PM Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies - 11/04/2019 - 11/04/2019

The purpose of the public hearing is to obtain public input on the state of the science regarding FMT to treat C. difficile infection not responsive to standard therapies, including the available clinical evidence for safety and effectiveness of FMT for this use and to better understand the impact of FDA’s enforcement policy on product development.

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October 02, 2019 at 03:21PM COAGADEX

•Indicated in adults and children with hereditary Factor X deficiency for:
◦Routine prophylaxis to reduce the frequency of bleeding episodes
◦On-demand treatment and control of bleeding episodes
◦Perioperative management of bleeding in patients with mild and moderate hereditary Factor X deficiency


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October 02, 2019 at 03:00PM IDELVION

Product approval information is indicated for children and adults with hemophilia B (congenital Factor IX deficiency) for 1) On-demand control and prevention of bleeding episodes; 2) Perioperative management of bleeding; 3) Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

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October 02, 2019 at 01:40PM Recalls (Biologics)

Biologic recalls are listed by year. Recalls are a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.

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October 01, 2019 at 08:10PM Section 8700: Medical Devices

This is the SOPP Section 8700: Medical Devices main page.

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October 01, 2019 at 04:20PM IXINITY

Indicated in adults and children ≥ 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management.

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October 01, 2019 at 03:55PM CANDIN

Submission Tracking Number (STN) BL 103257/5066 has been assigned to your recent supplement to your biologics license application for Candida albicans Skin Test Antigen for Cellular Hypersensitivity, CANDIN®, dated April 5, 2016. Your submission is in the form of a “Supplement – Changes Being Effected” as described under 21 CFR 601.12(c)(5).

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October 01, 2019 at 03:40PM Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus

This is the Draft Guidance for Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry.

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