December 30, 2019 at 04:27PM Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

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December 30, 2019 at 04:03PM Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

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December 30, 2019 at 02:52PM Roster of the Allergenic Products Advisory Committee

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

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2,300 unvaccinated students may not be allowed back to class, Seattle Public Schools warn - USA TODAY

1. 2,300 unvaccinated students may not be allowed back to class, Seattle Public Schools warn  USA TODAY
2. Measles vaccinations: Seattle public school students required to be vaccinated after outbreaks  CBS News
3. Seattle Schoolchildren Told Get Vaccinated or Don't Return to Class in 2020  Newsweek
4. Vaccination edict issued for Seattle public school students  ABC News
5. Seattle students barred from going to school until they're vaccinated  CBS This Morning
6. View full coverage on Google News

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December 26, 2019 at 07:22PM Removing Hair Safely

Tips for consumer about common methods of hair removal

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December 26, 2019 at 07:22PM FDA 101: Product Recalls

Here's a breakdown of FDA's role in product recalls, from the moment the agency is notified to successful completion of the recall.

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December 26, 2019 at 07:22PM FDA's International Posts: Improving the Safety of Imported Food and Medical Products

The posting of FDA staff in overseas regions is a key part of the agency's strategy for expanding oversight of imported food and medical products.

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December 26, 2019 at 07:21PM Use Caution With Ayurvedic Products

The presence of heavy metals in some Ayurvedic products makes them potentially harmful.

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December 26, 2019 at 07:21PM Are You Taking Medication as Prescribed?

Strategies for improving medication adherence.

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December 26, 2019 at 07:21PM FDA 101: Health Fraud Awareness

Learn how to spot health fraud and avoid it.

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December 26, 2019 at 07:20PM Facing Facts About Acne

Separating the facts from the myths can help people with acne treat the disease and keep it under control.

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December 26, 2019 at 07:20PM Problems Digesting Dairy Products?

Lactose intolerance can be managed by avoiding or eating less of certain foods and reading labels for hidden sources of lactose.

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December 26, 2019 at 07:20PM Reducing Radiation from Medical X-rays

Medical X-rays are an important tool for diagnosing and treating diseases, but they pose a small risk from radiation. Here's what you can do to reduce the risk.

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December 26, 2019 at 07:20PM Fortify Your Knowledge About Vitamins

Although most people get all the vitamins they need from the foods they eat, millions of people take supplemental vitamins as part of their health regimen. Here are facts about vitamins, including information on how they are regulated.

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December 26, 2019 at 07:20PM Food Allergies: Reducing the Risks

FDA is working to ensure that allergens in food are clearly and accurately labeled.

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December 26, 2019 at 07:20PM Hidden Risks of Erectile Dysfunction 'Treatments' Sold Online

FDA has found that some products marketed as dietary supplements for enhancing sexual performance contain undisclosed amounts of prescription drugs or similar substances that may be harmful

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December 26, 2019 at 07:20PM Start at the Store: 7 Ways to Prevent Foodborne Illness

Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home.

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December 26, 2019 at 07:17PM How Safe are Color Additives?

Basic information about the safety of color additives--dyes, pigments, or substances that can impart color when added or applied to a food, drug, cosmetic, or the human body.

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December 26, 2019 at 07:17PM OTC Cough and Cold Products: Not For Infants and Children Under 2 Years of Age

FDA strongly recommends that over-the-counter (OTC) cough and cold products should not be used in infants and children under 2 years of age

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December 26, 2019 at 07:22PM FDA 101: Product Recalls

Here's a breakdown of FDA's role in product recalls, from the moment the agency is notified to successful completion of the recall.

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December 26, 2019 at 07:21PM FDA 101: Health Fraud Awareness

Learn how to spot health fraud and avoid it.

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December 26, 2019 at 07:17PM FDA Export Certificates

This guidance document is intended to provide a general description of FDA Export Certificates to industry and foreign governments.

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December 26, 2019 at 07:17PM CPG Sec. 110.100 Certification for Exports

CPG Sec. 110.100 Certification for Exports

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December 26, 2019 at 04:44PM CBER Reports

This page contains a summary of regulatory, research, and administrative accomplishments for the last 2 fiscal years and related reports.

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December 26, 2019 at 04:37PM FY 2019 Report from the Director

Fiscal Year 2019 was an exciting time at CBER, as we continued to conduct important mission-oriented research and approved important new products that protect and improve public health. These included a novel gene therapy, vaccines, treatments for immune deficiencies, and tests for protection of the

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Listeria Concerns Prompt Massive Recall Of Egg Products - Newsweek

1. Listeria Concerns Prompt Massive Recall Of Egg Products  Newsweek
2. Hard-Boiled Egg Recall Expands to Products Sold at Walmart and Trader Joe’s Following Deadly Listeria Outbreak  KTLA Los Angeles
3. Trader Joe's Egg, Potato Salad Recall  CBS Los Angeles
4. Hard-boiled egg recall expands to Trader Joe’s products amid deadly listeria outbreak  WTOP
5. 88 egg products under recall after deadly listeria outbreak involving Georgia plant  11Alive
6. View full coverage on Google News

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Listeria Concerns Prompt Massive Recall Of Egg Products - Newsweek

1. Listeria Concerns Prompt Massive Recall Of Egg Products  Newsweek
2. 88 egg products under recall after deadly listeria outbreak involving Georgia plant  11Alive
3. Hard-boiled egg recall expands to new products  ABC News
4. Trader Joe's Egg, Potato Salad Recall  CBS Los Angeles
5. Listeria Prompts Egg-Product Recall | PatchPM  Patch.com
6. View full coverage on Google News

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A hard-boiled egg recall expands to products sold at Walmart and Trader Joe's following a deadly listeria outbreak - CNN

1. A hard-boiled egg recall expands to products sold at Walmart and Trader Joe's following a deadly listeria outbreak  CNN
2. Listeria Cases Prompt Egg-Products Recall In GA, Other States  Patch.com
3. 88 egg products under recall after deadly listeria outbreak involving Georgia plant  11Alive
4. Check your fridge: 88 egg products under recall after deadly listeria outbreak  WPMT FOX 43
5. 1 dead, 7 sick due to egg products under recall nationwide  Wink News
6. View full coverage on Google News

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A hard-boiled egg recall expands to products sold at Walmart and Trader Joe's following a deadly listeria outbreak - CNN

1. A hard-boiled egg recall expands to products sold at Walmart and Trader Joe's following a deadly listeria outbreak  CNN
2. Check your fridge: 88 egg products under recall after deadly listeria outbreak  WPMT FOX 43
3. 88 egg products under recall after deadly listeria outbreak involving Georgia plant  11Alive
4. 1 dead, 7 sick due to egg products under recall nationwide  Wink News
5. Egg recall: Hard-boiled eggs, egg products recalled from Walmart, Trader Joe's, more stores nationwide  USA TODAY
6. View full coverage on Google News

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Listeria Cases Prompt Egg-Products Recall, Including In Illinois - Patch.com

1. Listeria Cases Prompt Egg-Products Recall, Including In Illinois  Patch.com
2. Check your fridge: 88 egg products under recall after deadly listeria outbreak  WPMT FOX 43
3. Trader Joe’s recalls potato salad, egg salad because of listeria concerns  WXII12 Winston-Salem
4. Trader Joe's egg and old-fashioned potato salads recalled because of listeria fears  USA TODAY
5. Trader Joe's recalls egg white salad, potato salad amid Listeria concerns  KABC-TV
6. View full coverage on Google News

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Check your fridge: 88 egg products under recall after deadly listeria outbreak - WPMT FOX 43

Check your fridge: 88 egg products under recall after deadly listeria outbreak  WPMT FOX 43View full coverage on Google News

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December 24, 2019 at 06:30PM 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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December 23, 2019 at 08:04PM Section 8400: Marketing Applications

This is the SOPP Section 8400: Marketing Applications main page.

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December 23, 2019 at 07:56PM AFLURIA

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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December 23, 2019 at 07:48PM AFLURIA QUADRIVALENT

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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December 23, 2019 at 06:23PM Cleared 510(k) Submissions with Supporting Documents - 2019

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

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December 23, 2019 at 03:56PM Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

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December 23, 2019 at 03:12PM Requesting FDA Feedback on Combination Products

Draft guidance for industry and FDA staff: Requesting FDA Feedback on Combination Products

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December 23, 2019 at 02:51PM Administrative Guidances

This page lists Administrative Guidance documents.

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December 21, 2019 at 02:17AM 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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December 21, 2019 at 02:16AM Watch Out for False Promises About So-Called Alzheimer's Cures

Unfortunately, when faced with a serious health issue, even the most rational person can be led to believe implausible claims.

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December 21, 2019 at 02:16AM Malaria gene activity findings could form basis of improved test for monitoring disease spread

Scientists at the U.S. Food and Drug Administration (FDA), in collaboration with the Johns Hopkins Malaria Research Institute, identified changes in the expression of specific genes of human malaria parasite Plasmodium falciparum as they undergo development in the mosquito midgut.

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December 21, 2019 at 02:15AM 2019 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the CBER 2019 Meeting Materials, Vaccines and Related Biological Products Advisory Committee.

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December 21, 2019 at 02:15AM Vaccines and Related Biological Products Advisory Committee November 8, 2018 Meeting Webcast

This is the CBER Vaccines and Related Biological Products Advisory Committee November 8, 2018 Meeting Webcast.

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December 21, 2019 at 02:12AM VAXELIS

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3 dose series in children 6 weeks through 4 years of age (prior t

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December 21, 2019 at 02:12AM Vaccines and Related Biological Products Advisory Committee October 3, 2018 Meeting Webcast

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee October 3, 2018 Meeting Webcast.

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December 21, 2019 at 02:09AM Vaccines and Related Biological Products Advisory Committee October 3, 2018 Meeting Presentations

These are the Presentations for the October 3, 2018, Vaccines and Related Biological Products Advisory Committee Meeting, CBER, Biologics, VRBPAC

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December 21, 2019 at 02:09AM BAT (Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)

For the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients.

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December 21, 2019 at 02:08AM Genetic Systems HIV-1/HIV-2 Plus O EIA

Detection of antibodies to the Human Immunodeficiency Virus Types 1 and 2 in human serum and plasma

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December 21, 2019 at 02:08AM Chiron RIBA HCV 3.0 Strip Immunoblot Assay

Strip Immunoblot Assay including NS5 and c33c recombinant proteins and c100p, 5-1-1p and c22p synthetic peptides to detect antibodies to Hepatitis C Virus in human serum or plasma





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December 21, 2019 at 02:07AM Regenerative Medicine Update: Information for Industry on FDA’s Compliance and Enforcement Policy Regarding Certain Regulatory Requirements December 2018

The guidance on minimal manipulation/homologous use, issued in November 2017 (and corrected in December 2017), included information on the agency's compliance and enforcement policy regarding HCT/Ps. The FDA is now reminding industry that the enforcement discretion period ends in Nov 2020.

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December 21, 2019 at 02:06AM 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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December 21, 2019 at 02:05AM Universal influenza vaccine candidate reduces transmission of virus best when given nasally in mice

Scientists showed that the vaccine is more effective at reducing transmission of influenza.

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December 21, 2019 at 02:05AM BK180247: Capture-CMV

This is the main page for the CBER 501k BK180247: Capture-CMV.

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December 21, 2019 at 02:04AM Controle su asma: conozca los detonantes y sus opciones de tratamiento

Usted puede controlar su asma tomando medicamentos aprobados por la FDA; pero antes de ir a la farmacia, obtenga el diagnóstico apropiado de un médico y, juntos, tracen un plan de acción para controlarla.

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December 21, 2019 at 02:04AM Manage Your Asthma: Know Your Triggers and Treatment Options

Asthma is a chronic lung disease that causes the airways to become inflamed and narrow.

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December 21, 2019 at 01:59AM Recall Notification to Clients with Possible Product On-Hand, Effective 9/28/18

Consignees were instructed to not use the vials, due to reported adverse reactions.

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December 21, 2019 at 01:55AM Cord for Life, Inc. - 572770 - 03/29/2019

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


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December 21, 2019 at 01:53AM American Preclinical Services - 562382 - 02/12/2019

Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies


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December 21, 2019 at 01:53AM Genetech, Inc. - 561808 - 11/29/2018

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

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December 21, 2019 at 01:53AM University of Miami Reproductive and Fertility Center - 568208 - 12/03/2018

University of Miami Reproductive and Fertility Center, Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)


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December 21, 2019 at 01:53AM American Botanical Pharmacy - 562180 - 10/30/2018

American Botanical Pharmacy, Unapproved New Drugs/Misbranded


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December 20, 2019 at 05:04PM 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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December 20, 2019 at 04:51PM Vaccine and Related Biological Product Guidances

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

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December 20, 2019 at 01:15PM Systèmes et politiques d’innovation pour le secteur agricole en Amérique latine

Neuf études de cas nationales en Amérique latine passées au crible de l'analyse des processus d'innovation générées par les institutions scientifiques et technologiques. L'ouvrage Sistemas y políticas de innovación para el sector agropecuario en América Latina décrypte le rôle des institutions internationales dans la définition des agendas régionaux et la capacité du secteur privé à transformer les modes de production et de consommation. Il est issu du projet Polinco mené pendant 2 ans sur les politiques d’innovation agricole en Amérique Latine.

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December 17, 2019 at 09:08PM Cosméticos

Información para el consumidor sobre la seguridad de los cosméticos

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December 19, 2019 at 07:49PM Guidance for Industry Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act

Drug Safety

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December 19, 2019 at 02:43PM Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

Draft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

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December 19, 2019 at 02:27PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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December 19, 2019 at 01:53PM Considerations for the Development of Dried Plasma Products Intended for Transfusion

This guidance is intended to assist manufacturers, sponsors, and applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma1 products in the United States (U.S.).

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December 18, 2019 at 09:43PM Blood Grouping Reagents - ORTHO Sera

Product approval information is indicated for:
•ORTHO Sera Anti-D (DVI) is for the in vitro detection of human Rh D (DVI) positive red blood cells by the direct agglutination test. Patients and neonates should not be tested with this reagent since it detects partial RhD (DVI).
•ORTHO Sera Anti-D (IAT) is for the in vitro detection of human Rh D positive red blood cells by the indirect antiglobulin test.
•ORTHO Sera Anti-Lea is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test.
•ORTHO Sera Anti-Leb is for the qualitative in vitro detection of human Leb positive red blood cells by the direct agglutination test.
•ORTHO Sera Anti-N is for the qualitative in vitro detection of human N positive red blood cells by the direct agglutination test.

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December 18, 2019 at 09:42PM MTS Anti-IgG Card

Indicated For in vitro blood banking reagent

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December 18, 2019 at 09:06PM Bridging for Drug-Device and Biologic-Device Combination Products

Draft guidance for industry - Bridging for Drug-Device and Biologic-Device Combination Products

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December 18, 2019 at 02:39PM Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

Guidance for Industry: Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

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December 17, 2019 at 03:45PM YF-Vax

CBER Approved Product For active immunization of persons 9 months of age and older who:
•Are living in or traveling to endemic areas;
•Travelling internationally to countries that require evidence of vaccination from entering travelers or;
•Laboratory Personnel who might be expose to virulent yellow fever virus or to concentrated preparations of the yellow fever vaccine strain by direct or indirect contact or by aerosols should by vaccinated.

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December 17, 2019 at 03:43PM Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers

Guidance for Industry - Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers, Procedural

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December 17, 2019 at 03:40PM Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers

Guidance for Industry and Review Staff - Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers, Procedural

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Tornado outbreak strikes the Deep South - Washington Post

1. Tornado outbreak strikes the Deep South  Washington Post
2. 1 dead after dangerous long-tracking tornado strikes Louisiana  AccuWeather.com
3. Severe weather potential late Monday  WDSU New Orleans
4. Be weather aware: Isolated strong storms possible Monday night, Tuesday morning  WSB Atlanta
5. ALERT DAY: Several tornado warnings active  WLBT
6. View full coverage on Google News

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December 16, 2019 at 10:36PM Application Submissions Guidances

This page lists Application Submissions Guidance documents.

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December 16, 2019 at 08:29PM Wilate

Product approval information is indicated for children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes and perioperative management of bleeding.

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December 16, 2019 at 05:36PM Administrative Guidances

This page lists Administrative Guidance documents.

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December 16, 2019 at 04:43PM Tuberculin, Purified Protein Derivative - TUBERSOL

The product page for Tuberculin, Purified Protein Derivative - TUBERSOL containing the labeling and supporting documents

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December 16, 2019 at 03:09PM T.R.U.E. TEST

Product approval information for use as an aid in the diagnosis of allergic contact dermatitis in persons 6 years of age and older whose history suggests sensitivity to one or more of the 35 allergens and allergen mixes included on the T.R.U.E. TEST panels.

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December 16, 2019 at 02:52PM Boostrix

Boostrix is a product approval indicated for Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 10 years of age and older

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December 16, 2019 at 02:44PM Blood Establishment Registration and Product Listing

All owners or operators of establishments that manufacture blood products are required to register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65

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December 16, 2019 at 02:43PM Adacel

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

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December 11, 2019 at 05:36PM CIRAD was at the 2019 Salon de l’agriculture in Abidjan, a crucial event in terms of policy and strategy

The Ivory Coast Salon international de l’agriculture et des ressources animales (SARA) was held in Abidjan from 22 November to 1 December 2019. CIRAD, in association with AFD, made a subtantial contribution to the organization and success of the French presence at the event. SARA2019 placed France centre stage, and proved to be a crucial event in terms of agriculture, policy and strategy.

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December 13, 2019 at 08:28PM Remarks by Dr. Sharpless to the Research!America 2019 National Health Research Forum - 09/05/2019

Remarks by Ned Sharpless, M.D., Acting Commissioner of Food and Drugs, at the RESEARCH! AMERICA National Health Research Forum Program, "Leveraging Data to Accelerate Medical Progress,"
Thursday, September 5, 2019, Washington, D.C.

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December 13, 2019 at 07:48PM IMLYGIC (talimogene laherparepvec)

IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

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December 13, 2019 at 04:18PM ACAM2000

ACAM2000 is a product approval indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

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December 13, 2019 at 04:12PM eCopy Program for Medical Device Submissions

This guidance explains the eCopy Program for medical device submissions as well as implementation of this program by the FDA.

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December 12, 2019 at 09:33PM FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

This guidance establishes procedures for submitting, reviewing and responding to 513(g) requests for information regarding the classification and the regulatory requirements that may be applicable to a particular device.

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December 12, 2019 at 08:49PM Real-Time Premarket Approval Application (PMA) Supplements

This guidance provides information about the real-time review process for PMA supplements, outlines the criteria for Real-Time PMA Supplements and clarifies the kinds of device modifications FDA believes are appropriate for real-time review.

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December 12, 2019 at 08:12PM 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes

Provides guidance on the changes FDA believes may qualify for the 30-day notice and the changes that generally do not qualify.

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December 12, 2019 at 10:30PM Identification and Use of Biomarkers to Advance Development of Preventive Vaccines; Public Workshop - 09/16/2019 - 09/17/2019

The purpose of the public workshop is to exchange information with stakeholders from industry, academia, and government about the scientific, clinical, and regulatory challenges encountered in the identification, characterization, and qualification of biomarkers for use in the development of preventive vaccines for infectious diseases indications.

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December 12, 2019 at 04:30PM MedWatch Forms for FDA Safety Reporting

Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online.

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December 09, 2019 at 05:17PM Instructions for Completing Form FDA 3500

Instructions for Completing Form FDA 3500

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December 12, 2019 at 03:33PM FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act

Guidance for Industry: FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act


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December 12, 2019 at 12:48PM Recommendations from 46 experts, to ensure a sustainable, equitable future for Colombia

A group of 46 experts, including CIRAD President Managing Director Michel Eddi, met the Colombian President on 5 December to hand over their report on science, technology, innovation and education for the country's sustainable development over the coming two decades.

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December 12, 2019 at 12:48PM Les recommandations de 46 experts pour assurer un avenir durable et équitable à la Colombie

Un groupe de 46 experts, dont Michel Eddi, PDG du Cirad, a remis le 5 décembre dernier au Président de la Colombie un rapport sur la science, la technologie, l’innovation et l’éducation pour le développement durable du pays sur les 20 prochaines années.

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December 11, 2019 at 05:36PM Le Cirad au Salon de l’agriculture d'Abidjan 2019, rendez-vous politique et stratégique incontournable

Le Salon international de l’agriculture et des ressources animales (SARA) de Côte d’Ivoire s’est tenu du 22 novembre au 1er décembre 2019 à Abidjan. Le Cirad, en association avec l’AFD, a fortement contribué à l’organisation et à la réussite de la présence française à cet événement. Avec, cette année, la France à l’honneur, le SARA2019 a constitué un rendez-vous scientifique, politique et stratégique incontournable.

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December 11, 2019 at 10:41PM Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

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December 11, 2019 at 08:39PM DG Gel Card 125445, 125449, 125450 - 125457

Product approval information is for:
•DG Gel 8 AB (x4) card is for the determination of human A and B antigen on the surface of red blood cells in four separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 A/B/D card is for the determination of human A, B and D antigens on the surface of red blood cells in two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse grouping, and D and Kell antigens on the surface of red blood cells in human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells in two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test in human blood samples. This assay does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 Anti-IgG (Rabbit) card is for the Direct and Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components.

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December 11, 2019 at 06:02PM Having Naloxone on Hand Can Save a Life During an Opioid Overdose

Anyone can save a life during an opioid overdose with naloxone, a front-line defense in the opioid crisis. Naloxone is a life-saving drug that quickly reverses the powerful effects of opioids. FDA is working to give more people access to naloxone.

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December 11, 2019 at 01:37PM Diagast Bundled BLA 125615, 125619 to 125626

Diagast Bundled BLA 125615, 125619 to 125626

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December 11, 2019 at 02:39PM DG Gel Cards

Product approval information is for:
•DG Gel 8 AB (x4) card is for the determination of human A and B antigen on the surface of red blood cells in four separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 A/B/D card is for the determination of human A, B and D antigens on the surface of red blood cells in two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse grouping, and D and Kell antigens on the surface of red blood cells in human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells in two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test in human blood samples. This assay does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 Anti-IgG (Rabbit) card is for the Direct and Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components.

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December 11, 2019 at 02:13PM Prevnar 13

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

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December 10, 2019 at 07:36PM Health Fraud Scams

Learn how to spot health fraud and avoid it.

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December 09, 2019 at 05:25PM The pastoral landscapes of the Sahel are mitigating climate change

Whereas livestock production often stands accused of being a one of the agricutlural activities that generate the most greenhouse gases, in some situations, it can in fact indirectly mitigate climate change. Researchers from CIRAD have shown that certain pastoral zones in the Sahel have a negative carbon balance. This startling fact could prompt greater state involvement in such zones, hence contributing to their development and stabilization.

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December 09, 2019 at 03:58PM Arabica coffee: Starmaya, a hybrid variety available in seed form for the first time

A team from CIRAD has developed the first Arabica F1 hybrid produced from seed and suitable for sale on a large scale. The seeds of the variety, called Starmaya, cost half as much to produce as the coffee F1 hybrid in vitro plantlets currently available. This is a minor revolution for the coffee industry.

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December 09, 2019 at 05:22PM Animal & Veterinary

Consumer articles from FDA about animal health and veterinary medicine.

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December 09, 2019 at 05:25PM Au Sahel, les territoires d’élevage atténuent le changement climatique

A l’heure où l’élevage est souvent pointé du doigt comme une source importante de gaz à effets de serre parmi les activités agricoles, il peut dans certains contextes contribuer indirectement à l’atténuation du changement climatique. Des chercheurs du Cirad ont montré que certains territoires pastoraux, au Sahel, présentent un bilan carbone négatif. Des données surprenantes qui pourraient favoriser une implication plus importante des Etats dans ces territoires et ainsi contribuer à leurs développement et stabilisation.

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December 09, 2019 at 04:32PM TENIVAC

TENIVAC is a product approval Indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.

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December 09, 2019 at 03:58PM Café Arabica : Starmaya, une variété hybride disponible pour la première fois sous forme de graines

Une équipe du Cirad a mis au point le premier hybride F1 d’Arabica produit par graine et commercialisable à grande échelle. Les graines de cette variété, nommée Starmaya, sont deux fois moins coûteuses à produire que les vitro-plants hybrides F1 de café actuellement disponibles sur le marché. Une petite révolution pour l’industrie du café.

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December 09, 2019 at 03:40PM TRG Rapid Inquiry Program (TRIP)

TRG Rapid Inquiry Program (TRIP) is a temporary program of the TRG to assist stakeholders with questions about how specific HCT/Ps are regulated.

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December 06, 2019 at 08:47PM 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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December 06, 2019 at 08:25PM Liveyon Labs Inc - 588399 - 12/05/2019

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


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December 06, 2019 at 04:42PM CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor

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December 05, 2019 at 08:40PM Don't Double Up on Acetaminophen

More than 600 medications, both prescription and over-the-counter (OTC), contain the active ingredient acetaminophen to help relieve pain and reduce fever. Taken carefully and correctly, these medicines can be safe and effective. But taking too much acetaminophen can lead to severe liver damage.

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December 05, 2019 at 04:58PM Panoscreen EXTEND

Detection of expected and unexpected red cell blood group antibodies

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December 05, 2019 at 04:40PM CBER Reports

This page contains a summary of regulatory, research, and administrative accomplishments for the last 2 fiscal years and related reports.

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December 05, 2019 at 01:31PM Physician, Division of Epidemiology (DE) - Title 38(F) Physician (GP-0602)

The Center for Biologics Evaluation and Research is recruiting to fill a Physician position to serve in the Division of Epidemiology in the Office of Biostatistics and Epidemiology.

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December 04, 2019 at 05:24PM Instructions for Completing Form FDA 3500

Instructions for Completing Form FDA 3500

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December 04, 2019 at 03:07PM BK190389 - ALBAcheck BGS Monoclonal Control

ALBAcheck® BGS Monoclonal Control is intended for use as a negative control in conjunction with ALBAclone® Blood Grouping reagents (where referenced in the reagent IFU).

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December 03, 2019 at 04:49PM Clinical Guidances

This page lists Clinical Guidance documents.

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December 03, 2019 at 10:38AM Climate | Developing organic fertilization, for more sustainable, resilient agriculture

CIRAD and its partners have submitted a contribution on the topic of fertilization to the UN Framework Convention on Climate Change. This is the fourth contribution under the Koronivia Joint Work on Agriculture (KJWA) aimed at ensuring that agriculture is included in climate talks. This latest appraisal concerns the use of nutrients for more sustainable, resilient farming systems. A workshop is scheduled on the topic on 3 and 4 December, at COP25 in Madrid. The key messages of the contribution are set out below.

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December 03, 2019 at 02:54AM Smoke testing 12-02 Release

Smoke testing 12-02 Release

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December 03, 2019 at 12:15AM FDA-Approved Devices That Help Keep the Heart Beating

Cardiovascular devices (or heart devices) such as pacemakers and defibrillators have extended and improved the lives of millions of people worldwide. Learn how the FDA regulates these devices, when to seek medical attention for potential heart issues, and how to report problems.

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December 02, 2019 at 10:58PM Facilitating End-to-End Development of Individualized Therapeutics - 03/03/2020 - 03/03/2020

The purpose of the public workshop is to foster development of individualized therapeutic products for the treatment of one individual or a very small number of patients, based on engineering a product aimed at the specific molecular mechanism underlying a patient’s (or small group of patients’) illness.

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Passengers from Norwegian Joy cruise ship are treated for illness for the second time in a week - CNN

1. Passengers from Norwegian Joy cruise ship are treated for illness for the second time in a week  CNN
2. Norwegian cruise ship docks, 19 people treated for flu-like symptoms, officials say  Fox News
3. News 19 people report illness on cruise ship in California Associated Press 9:35 AM, Dec  10News
4. Norwegian Cruise Lines ship has second outbreak in two weeks  FOX 11 Los Angeles
5. More passengers fall ill on Norwegian Joy cruise ship  Los Angeles Times
6. View full coverage on Google News

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