September 30, 2019 at 10:40PM The FDA Encourages New Treatments for Sickle Cell Disease

The U.S. Food and Drug Administration is collaborating with patients, academics, and the pharmaceutical industry to encourage the development of new treatments for sickle cell disease (SCD).

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September 30, 2019 at 10:40PM The FDA Encourages New Treatments for Sickle Cell Disease

The U.S. Food and Drug Administration is collaborating with patients, academics, and the pharmaceutical industry to encourage the development of new treatments for sickle cell disease (SCD).

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September 30, 2019 at 10:35PM Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes

Use the following list of Biological Product Deviation (BPD) Codes to assign a specific code to a reportable event when you submit the report to FDA. Use the guidance document, "Biological Product Deviation Reporting for Blood and Plasma Establishments," (https://ift.tt/2oKXjsp) to determine if you must report an event. The list includes deviations from regulations, standards, and standard operating procedures (SOPs) that may affect the safety, purity, or potency of a product. These codes may not apply to all establishments because they include deviations and unexpected events related to SOPs implemented at individual establishments and may not be an industry standard or a procedure at your facility. The use of BPD Codes will assist the FDA in analyzing the data submitted and streamline the trend analysis.

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September 30, 2019 at 10:30PM Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes

This is the main page for the Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes.

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September 30, 2019 at 10:30PM Biological Product Deviation Reporting -- Blood Product Codes

This is the main page for the Biological Product Deviation Reporting - Blood Product Codes.

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September 30, 2019 at 09:25PM Substantially Equivalent 510(k) Device Information

Listing of 510(k) submissions

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September 30, 2019 at 09:05PM BabyBIG

Product approval information is indicated for Treatment of infant botulism caused by type A or type B in patients below one year of age.

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September 30, 2019 at 08:15PM 2017 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the 2017 Meeting Materials, Vaccines and Related Biological Products Advisory Committee lead page

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September 30, 2019 at 08:15PM 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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September 30, 2019 at 07:45PM MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane)

MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults.

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September 30, 2019 at 03:45PM Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations

From Patient Engagement Advisory Committee recommendations, this draft guidance describes engagement of patient advisors in design and conduct of device trials.

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September 30, 2019 at 03:45PM Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act

This guidance describes the development of electronic submission templates that will serve as guided submission preparation tools for industry.

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September 30, 2019 at 03:45PM The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

FDA issues draft guidance on the Accreditation Scheme for Conformity Assessment (ASCA) Pilot for Industry, Accreditation Bodies, Testing Laboratories, and FDA.

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September 30, 2019 at 02:55PM Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion

Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion, Draft Guidance for Industry, CBER, Biologics, December 2018

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September 30, 2019 at 02:48PM Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders

Procedural Guidance

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September 30, 2019 at 02:25PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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September 30, 2019 at 02:25PM Recently Issued Guidance Documents

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

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September 30, 2019 at 02:25PM Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion

This is the Guidance for industry, Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion.

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As vape lung death toll mounts, CDC investigators warn against ‘informal’ THC sources - TechCrunch

1. As vape lung death toll mounts, CDC investigators warn against ‘informal’ THC sources  TechCrunch
2. Dank Vapes, TKO and Other THC Vaping Brands Are Linked to Illnesses, C.D.C. Says  The New York Times
3. CDC reveals new info about vaping epidemic  WCNC
4. US CDC recommends against using vapes with marijuana ingredient  CNA
5. Market Wrap: CDC Ties THC to Vaping Disease Outbreak  TheStreet.com
6. View full coverage on Google News

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September 27, 2019 at 09:00PM 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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CDC urges people to avoid vaping THC amid lung disease outbreak - CNBC

1. CDC urges people to avoid vaping THC amid lung disease outbreak  CNBC
2. Vaping-Related Illnesses Climb to 805, C.D.C. Says  The New York Times
3. Florida attorney general 'highly alarmed' about vaping-related illness after first death in state  WFTV Orlando
4. Dank Vapes, TKO and Other THC Vaping Brands Linked to Illnesses, C.D.C. Says  The New York Times
5. Florida, Georgia see first vaping-related deaths as nationwide toll hits 12  Fox News
6. View full coverage on Google News

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September 27, 2019 at 08:00PM Delivering Promising New Medicines Without Sacrificing Safety and Efficacy

All drugs approved under the Fast Track, Breakthrough Therapy, RMAT designation, and Priority Review expedited programs are held to the same approval standards as other FDA drug approvals.

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September 27, 2019 at 07:21PM Antimicrobial Resistance Information from FDA

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

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September 27, 2019 at 04:35PM AFSTYLA

AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain, is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
• On-demand treatment and control of bleeding episodes,
• Routine prophylaxis to reduce the frequency of bleeding episodes,
• Perioperative management of bleeding.

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September 27, 2019 at 04:20PM OBIZUR

Product approval information is indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.

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September 27, 2019 at 03:10PM Section 8400: Marketing Applications

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

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September 27, 2019 at 02:55PM ADYNOVATE

Product approval information is indicated for children and adults with hemophilia A (congenital factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes; (2) Perioperative management; (3) Routine prophylaxis to reduce the frequency of bleeding episodes.

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September 27, 2019 at 01:15PM ELOCTATE

Product approval information is indicated for adults and children with Hemophilia A for (1) on-demand treatment and control of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

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September 26, 2019 at 10:15PM NUWIQ

Product approval information is indicated for adults and children with Hemophilia A for:
• On-demand treatment and control of bleeding episodes
• Perioperative management of bleeding
• Routine prophylaxis to reduce the frequency of bleeding episodes

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September 26, 2019 at 09:36PM KOVALTRY

KOVALTRY®, Antihemophilic Factor (Recombinant), is a recombinant,
human DNA sequence derived, full length Factor VIII concentrate indicated
for use in adults and children with hemophilia A (congenital Factor VIII
deficiency) for:
 On-demand treatment and control of bleeding episodes
 Perioperative management of bleeding
 Routine prophylaxis to reduce the frequency of bleeding episodes

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September 26, 2019 at 08:00PM ORALAIR

Product approval information for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 10 through 65 years of age.

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September 26, 2019 at 07:10PM GRASTEK

Product approval information for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. GRASTEK is approved for use in persons 5 through 65 years of age

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September 26, 2019 at 06:51PM Adenovirus Type 4 and Type 7 Vaccine, Live, Oral

Indicated for active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7

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September 26, 2019 at 02:55PM Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

This guidance provides FDA's current thinking on hardware and software functions that transfer, store, convert formats, and display medical device data.

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September 26, 2019 at 02:52PM Policy for Device Software Functions and Mobile Medical Applications

This guidance provides FDA's current thinking regarding the software functions and mobile apps to which the FDA intends to apply its authority.

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September 26, 2019 at 02:45PM Clinical Decision Support Software

This guidance provides clarity on the scope of FDA's oversight of clinical decision support software intended for health care professionals, patients, or caregivers.

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September 26, 2019 at 02:45PM Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act

This guidance provides FDA's current thinking regarding the amended device definition as a result of section 3060(a) of the Cures Act.

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September 25, 2019 at 08:10PM Halloween Safety: Costumes, Candy, and Colored Contact Lenses

Enjoy a happy and safe Halloween by following these guidelines from FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention.

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September 25, 2019 at 04:00PM Administrative Guidances

This page lists Administrative Guidance documents.

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September 25, 2019 at 02:35PM Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act

This guidance describes the development of electronic submission templates that will serve as guided submission preparation tools for industry.

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September 24, 2019 at 09:23PM 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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September 23, 2019 at 01:52PM Urban food policy: Montpellier, 2019 capital of the Milan Pact

From 7 to 9 October, the city of Montpellier will host more than 100 mayors from the 197 signatory cities to the Milan Urban Food Policy Pact. Since 2015, they have all committed to moving towards sustainable food systems. CIRAD, leveraging its many years of global expertise, will be taking part in this international event, alongside the Agropolis community, gathering under the aegis of the UNESCO Chair in World Food Systems.

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September 24, 2019 at 04:00PM FDALabel: Full-Text Search of Drug Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 100,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

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September 24, 2019 at 01:45PM News & Events (Biologics)

Information on recently posted Web pages, meetings, conferences, and workshops.

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September 23, 2019 at 08:00PM Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents

list includes applications for which we have approval documents available, and reflects the information as of the approval date. It is not updated with regard to applicant or application status changes. Information is arranged in alphabetical order by the name of the applicant.

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September 23, 2019 at 06:51PM Black Licorice: Trick or Treat?

Black licorice is an old fashioned treat that can be harmful if you eat too much. If you're 40 or older, eating 2 ounces of black licorice a day for two weeks could cause an irregular heart rhythm (arrhythmia).

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September 23, 2019 at 05:19PM Designing Urban Food Policies

While the 5th meeting of the signatory cities of the Milan Pact will start very soon, a scientific book on urban food policies has just been published in English and open access. Written by a group of researchers, this book is the result of work carried out within the scientific community of Agropolis International as part of the Surfood program.

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September 23, 2019 at 05:19PM Construire des politiques alimentaires urbaines

Alors que démarre très prochainement la 5e rencontre des villes signataires du pacte de Milan, un ouvrage scientifique sur les politiques alimentaires urbaines vient de paraitre en anglais et en accès libre. Rédigé par un collectif de chercheurs, donc plusieurs du Cirad, ce livre est le fruit de travaux menés au sein de la communauté scientifique d’Agropolis International dans le cadre du programme Surfood.

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September 23, 2019 at 04:50PM Fête de la science 2019 à Montpellier | Voyagez au cœur des plantes et de leur environnement avec le Cirad

Comme chaque année, le Cirad apporte sa contribution à la Fête de la science. En 2019, des thématiques variées, des ateliers et des animations ludiques pour illustrer une science captivante. A Montpellier, venez rencontrer les chercheurs du Cirad du 5 au 11 octobre. Découvrez les savoirs pour mieux comprendre le monde qui nous entoure !

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September 23, 2019 at 01:43PM Zero Hunger By 2030: Our Shared Challenge! Drivers of change and sustainable food systems

Agricultural Research for Development Conference 2019. Avec la participation du Cirad.

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September 23, 2019 at 02:51PM Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations

From Patient Engagement Advisory Committee recommendations, this draft guidance describes engagement of patient advisors in design and conduct of device trials.

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September 23, 2019 at 01:52PM Alimentation urbaine : Montpellier, capitale 2019 du Pacte de Milan

Du 7 au 9 octobre, la ville de Montpellier accueille plus d’une centaine de maires des 197 villes signataires du Pacte de politique alimentaire urbaine de Milan. Depuis 2015, tous se sont engagés à aller dans le sens de systèmes alimentaires durables. Le Cirad, fort d’une expertise longue et globale, participe à cet événement international, au côté de la communauté Agropolis, réunie sous l’égide de la chaire Unesco Alimentations du monde.

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September 20, 2019 at 02:49PM Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products

Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products, Draft Guidance, Level 1, CBER, CDER Biologics, Drugs, September 2019

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September 20, 2019 at 02:30PM The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

FDA issues draft guidance on the Accreditation Scheme for Conformity Assessment (ASCA) Pilot for Industry, Accreditation Bodies, Testing Laboratories, and FDA.

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Cleared 510(k) Submissions with Supporting Documents - 2019

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

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Flucelvax Quadrivalent

For active immunization of children and adolescents 4 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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FDA’s Comprehensive Response to HIV — Part II

FDA plays a pivotal role in advancing HIV therapies in underserved global markets through the President’s Emergency Plan for AIDS Relief (PEPFAR).

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September 19, 2019 at 03:30PM How might rice growing react to climate change?

To find out, CIRAD researchers simulated the climate we are likely to have in 30 years' time, in a high-tech laboratory. The conclusion was that depending on the rice variety, photosynthesis and production were boosted, albeit to varying extents, by an increase in atmospheric CO2. Morphology, notably the leaf:panicle ratio, could determine a plant's capacity to benefit from increased CO2. This research will be an asset in steering future varietal breeding programmes, as shown in this video, in the run-up to next week's UN Climate Action Summit.

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September 19, 2019 at 03:30PM Comment la culture du riz va-t-elle réagir au changement climatique ?

Pour le savoir, les scientifiques du Cirad ont simulé le climat que nous devrions connaitre d’ici 30 ans dans une serre à la pointe de la technologie. Résultat : selon la variété de riz, la photosynthèse et la production sont plus ou moins boostées par une augmentation de CO2 atmosphérique. La morphologie, notamment au travers du rapport feuille/panicule, pourrait déterminer la capacité de la plante à mieux profiter d'une hausse de CO2. Des recherches précieuses pour orienter les programmes de sélection variétale de demain, à découvrir en vidéo alors que le sommet Action Climat de l’ONU démarre lundi.

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Safety and Performance Based Pathway

Current thinking on expanding the concept of the Abbreviated 510(k) Program for demonstrating substantial equiv. for premarket notification 510(k) submissions.

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Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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FDA’s Comprehensive Response to HIV — Part I

A multidisciplinary review and oversight program helps spur the development of effective treatments and approval of an expanding number of HIV drugs and drug combinations.

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DENGVAXIA

DENGVAXIA is Indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

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Safer Technologies Program for Medical Devices

A new, voluntary program for medical devices that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics.

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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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TCPro simulates immune system response to biotherapeutic drugs

TCPro simulates immune system response to biotherapeutic drugs

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TCPro simulates immune system response to biotherapeutic drugs

TCPro simulates immune system response to biotherapeutic drugs

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Susan P. King-Harris, D.P.M. - 591682 - 09/09/2019

Bioresearch Monitoring Program/IRB

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Expanded Access to Experimental Biologics

Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtai

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September 13, 2019 at 03:09PM Forest fires: what are the priorities for action in Africa and the Amazon?

Since the start of the summer, major fires have spread through Amazonia and central Africa. They have alerted the entire world to the need to manage forests and territories effectively. CIRAD is using its multi-disciplinary expertise and field experience to support local players in the fight against deforestation and degradation and promote forest landscape restoration.

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Select CBER Projects and Activities

CBER projects and activities that address the 21st Century Cures Act and the Prescription Drug User Fees Act VI Reauthorization (PDUFA VI) as authorized by the FDA Reauthorization Act (FDARA)

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International Activities

CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.

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September 13, 2019 at 03:09PM Incendies de forêt : quelles sont les priorités d’action pour l’Afrique et l’Amazonie

Depuis le début de l’été, d’importants incendies se sont répandus en Amazonie et en Afrique centrale. Ces phénomènes attirent l’attention de la planète entière sur la nécessité d’une bonne gestion des forêts et des territoires. Le Cirad met à profit ses compétences pluridisciplinaires et son expertise du terrain pour accompagner les acteurs locaux dans la lutte contre la déforestation, la dégradation et pour promouvoir la restauration des paysages forestiers.

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Safety & Availability (Biologics)

Important information about the safety and availability of biological products.

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CBER Biologics Effectiveness and Safety (BEST) System

This is the main page for CBER's Biologics Effectiveness and Safety (BEST) System.

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December 09, 2019 at 02:25PM Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants Guidance for Industry

Guidance for Industry

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December 09, 2019 at 09:38AM The Abbreviated 510(k) Program

This guidance provides the framework that FDA uses when considering whether a 510(k) is appropriate for review as an Abbreviated 510(k).

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December 09, 2019 at 09:37AM Format for Traditional and Abbreviated 510(k)s

This guidance provides instruction on how to format a Traditional or Abbreviated 510(k).

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December 09, 2019 at 09:36AM Refuse to Accept Policy for 510(k)s

Procedures and criteria used in assessing whether a 510(k) submission meets minimum threshold of acceptability and should be accepted for substantive review.

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December 09, 2019 at 09:36AM The Special 510(k) Program

This guidance provides the framework that FDA uses when considering whether a 510(k) is appropriate for review as a Special 510(k).

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December 09, 2019 at 07:36AM Cleared 510(k) Submissions with Supporting Documents

Listing of cleared 510(k) submissions with supporting documents. Information is reflected as of the clearance date.

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Juul threw millions of dollars at Washington. It hasn’t bought much. - POLITICO

1. Juul threw millions of dollars at Washington. It hasn’t bought much.  POLITICO
2. Trump administration readies ban on flavored e-cigarettes amid  CNBC
3. Trump announces crackdown on flavored e-cigarettes  CBS News
4. Melania Trump outrage: FLOTUS savaged on Twitter for shocking post on 9/11 anniversary  Express.co.uk
5. Trump administration moves to ban flavored e-cigarettes  CNN
6. View full coverage on Google News

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Trump administration moves to ban flavored e-cigarettes - CNN

1. Trump administration moves to ban flavored e-cigarettes  CNN
2. Trump administration readies ban on flavored e-cigarettes amid outbreak of vaping-related deaths  CNBC
3. Trump announces crackdown on flavored e-cigarettes  CBS News
4. Trump administration plans to ban sale of flavored electronic cigarettes  NBC News
5. Government will propose banning flavors used in e-cigarettes  WTOP
6. View full coverage on Google News

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September 09, 2019 at 05:35PM Marisa Peyre: "Public-private partnerships have considerable potential to boost veterinary services"

Marisa Peyre, an epidemiologist with CIRAD, contributed to the drafting of a handbook on public-private partnerships in the veterinary field, a guide to good practice published by the OIE with the support of the Bill and Melinda Gates Foundation. She sets out the main conditions for the success of such partnerships, with the help of success stories gathered from OIE members.

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November 09, 2019 at 02:33AM Statement on data accuracy issues with recently approved gene therapy

Statement by Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on data accuracy issues with recently approved gene therapy

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November 09, 2019 at 02:16AM FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions

FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions

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November 09, 2019 at 02:12AM Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law

Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law

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November 09, 2019 at 01:43AM Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

Helping to facilitate access to promising medicines for patients with serious or immediately life-threatening diseases or conditions when no comparable or satisfactory alternative therapy options are available is a high priority for the FDA

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November 09, 2019 at 01:27AM Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s role in preparing for flu season

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October 10, 2019 at 01:06AM La FDA investiga para acelerar la creación de vacunas y terapias contra el virus del Zika

Un nuevo modelo a base de ratones diseñado por científicos de la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) podría ayudar a explorar la posible actividad de las vacunas y terapias contra el virus del Zika. Publicado hoy en PLoS Pathogens, es la descripción de un modelo a base de ratones neonatos que proporciona una plataforma para, posiblemente, mejorar y agilizar los estudios que permitan entender las causas y los efectos (la patología) del virus del Zika.

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October 10, 2019 at 12:33AM Primera vacuna aprobada por la FDA para prevenir la enfermedad meningocócica causada por el serogrupo B

La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de los Estados Unidos anunció hoy la aprobación del Trumenba, la primera vacuna autorizada en los Estados Unidos para prevenir la enfermedad meningocócica invasiva causada por el serogrupo B de la Neisseria meningitidis en personas de entre 10 y 25 años de edad.

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October 09, 2019 at 01:16PM Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies

Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; final; C. difficile infection, Fecal microbiota, CBER, Biologics

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October 09, 2019 at 01:10PM 2019 Meeting Materials, Allergenic Products Advisory Committee

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

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October 09, 2019 at 12:35PM 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 09, 2019 at 11:25AM 0.9 % Sodium Chloride Injection USP

A pre-attached subassembly component of an apheresis kit for apheresis kit priming and/or for use as a replenishment fluid to maintain isovolemia in subjects undergoing an apheresis procedure.

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September 09, 2019 at 07:18PM FDA identifies biomarker for immune response to FVIII products used to treat hemophilia A

FDA identifies biomarker for immune response to FVIII products used to treat hemophilia A

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September 09, 2019 at 02:45PM 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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September 09, 2019 at 05:35PM Marisa Peyre : « Les partenariats public-privé offrent un potentiel considérable pour renforcer les services vétérinaires »

Épidémiologiste au Cirad, Marisa Peyre a participé à la conception d’un manuel sur les partenariats public-privé dans le domaine vétérinaire. Ce guide de bonnes pratiques est édité par l’OIE avec le soutien de la Fondation Bill et Melinda Gates. La chercheuse détaille les grands principes de réussite de ces accords, en les illustrant de « success stories » récoltées auprès des membres de l’OIE.

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September 09, 2019 at 10:55AM 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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September 09, 2019 at 10:50AM 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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September 05, 2019 at 11:18AM 4th TEAM meeting on fruit flies

4th International TEAM (Working Group on Tephritidae in Europe, Africa and the Middle East), co-organized by CIRAD. Event held every four years.

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September 04, 2019 at 02:55PM International symposium: "Biodiversité végétale et développement durable"

International symposium on plant biodiversity and sustainable development, with the participation of CIRAD. The symposium will mark the end of the Sud Expert Plantes Développement Durable (SEP2D) programme , funded by AFD, FFEM, MEAE, IRD and MNHN. the event, co-organized with Abomey-Calavi University, is open to the whole of the scientific community and to plant biodiversity management players and users.

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September 05, 2019 at 11:18AM 4e congrès TEAM sur les mouches des fruits

La 4e réunion du congrès TEAM (groupe de travail sur les Tephritidae en Europe, en Afrique et au Moyen-Orient) est coorganisée par le Cirad. Cet événement est organisé tous les 4 ans.

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September 05, 2019 at 11:10AM Ecoaquaconference

Une conférence internationale organisée avec le soutien et la participation du Cirad sur le thème "Intensification écologique : un nouveau modèle pour l'aquaculture durable".

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September 04, 2019 at 02:55PM Symposium International "Biodiversité végétale et développement durable"

Avec la participation du Cirad. Ce symposium clôture le programme Sud Expert Plantes Développement Durable (SEP2D), financé par l’AFD, le FFEM, le MEAE, l’IRD et le MNHN. L’événement, coorganisé avec l'Université d'Abomey-Calavi, est ouvert à l’ensemble de la communauté scientifique et aux acteurs de la gestion et valorisation de la biodiversité végétale.

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August 30, 2019 at 05:30PM Improving veterinary services through public-private partnerships

The World Organisation for Animal Health (OIE) has just published a Handbook of guidelines for successful public-private partnerships in the veterinary domain. This work was conducted by OIE and CIRAD, with the support of the Bill & Melinda Gates Foundation.

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Texas shooting: State introduces raft of weaker gun laws a day after seven killed in latest outbreak of violence - The Independent

Texas shooting: State introduces raft of weaker gun laws a day after seven killed in latest outbreak of violence  The Independent

As Texas reels from its second mass shooting in a month, a raft of new state laws have come into effect loosening regulations and easing access to guns.

View full coverage on Google News

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