Friday, November 29, 2019

Arkansas vs. Missouri score: Tigers retain Battle Line trophy with fourth straight win over Razorbacks - CBSSports.com

  1. Arkansas vs. Missouri score: Tigers retain Battle Line trophy with fourth straight win over Razorbacks  CBSSports.com
  2. Numerous Arkansas Players, Coaches Out vs. Missouri Due to Mumps Outbreak  Bleacher Report
  3. Hogs look to new era after 24-14 season-ending loss to Missouri  247Sports
  4. Tailgating at War Memorial Stadium, Missouri vs. Arkansas  THV11
  5. Hogs fall to Tigers 24-14 in season finale  WholeHogSports
  6. View full coverage on Google News


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November 29, 2019 at 04:45PM Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry

Clinical / Medical

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November 29, 2019 at 02:35PM CIRAD will be at COP25

CIRAD, along with its partners, will be involved in several side events at COP25 in Madrid, beginning on Monday 2 December. This is an important step in the talks between countries prior to implementation of the Paris agreement, scheduled for 2020. The summit also marks the final year of the Koronivia joint work on agriculture, decided during COP23 in Bonn.



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November 29, 2019 at 04:26PM Adaptive Design Clinical Trials for Drugs and Biologics

Clinical / Medical

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November 29, 2019 at 02:35PM Retrouvez le Cirad pendant la COP 25

Le Cirad sera impliqué, avec ses partenaires, dans plusieurs évènements en parallèle de la COP 25 qui démarre lundi 2 décembre à Madrid. Un rendez-vous important pour les négociations des Etats avant la mise en œuvre de l’accord de Paris prévu en 2020. Ce sommet marque aussi la dernière année de l’action commune de Koronivia pour l’agriculture, adoptée à Bonn lors de la COP 23.



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Wednesday, November 27, 2019

Romaine lettuce from CA linked to E. coli outbreak that has infected 67 people in US - ABC News

  1. Romaine lettuce from CA linked to E. coli outbreak that has infected 67 people in US  ABC News
  2. 67 E. coli infections across 19 states are linked to romaine lettuce, CDC says  CNN
  3. Sam’s club issues lettuce recall  WTAJ - www.wearecentralpa.com
  4. 67 E. coli infections in 19 states linked to romaine lettuce  10News
  5. Growing Outbreak: Romaine Lettuce Linked To 67 Cases Of E.Coli, CDC Warns | NBC Nightly News  NBC News
  6. View full coverage on Google News


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Romaine lettuce from CA linked to E. coli outbreak that has infected 67 people in US - ABC News

  1. Romaine lettuce from CA linked to E. coli outbreak that has infected 67 people in US  ABC News
  2. 67 E. coli infections across 19 states are linked to romaine lettuce, CDC says  CNN
  3. Public Health probing possible E. coli outbreak at Seattle salad shop  MyNorthwest.com
  4. 67 E. coli infections in 19 states linked to romaine lettuce  10News
  5. Growing Outbreak: Romaine Lettuce Linked To 67 Cases Of E.Coli, CDC Warns | NBC Nightly News  NBC News
  6. View full coverage on Google News


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November 27, 2019 at 08:17PM Vaccines Licensed for Use in the United States

The product name and trade name of vaccines licensed for use in the United States.

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November 27, 2019 at 06:28PM Le virus Ebola est-il bien transmis par les chauves-souris ?

Même si de nombreuses évidences épidémiologiques l’indiquent, la preuve irréfutable que les chauves-souris sont bien les réservoirs du virus Ebola n’a jamais pu être apportée. En effet, le virus actif n’a jamais été retrouvé chez aucune espèce de chiroptère. Dans la cadre du projet Ebo-Sursy, les chercheurs du Cirad en partenariat avec l’IRD, Institut Pasteur et l’OIE proposent une approche novatrice pour mener à bien cette quête.



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November 27, 2019 at 07:56PM Labeling of Red Blood Cell Units with Historical Antigen Typing Results

Labeling of Red Blood Cell Units with Historical Antigen Typing Results guidance for industry, CBER, Biologics, Blood

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November 27, 2019 at 04:42PM Administrative Actions (Biologics)

This is the main page for the CBER Administrative Actions (Biologics).

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Romaine lettuce E. coli outbreak tied to California region hits 67 cases - Fox News

  1. Romaine lettuce E. coli outbreak tied to California region hits 67 cases  Fox News
  2. Growing Outbreak: Romaine Lettuce Linked To 67 Cases Of E.Coli, CDC Warns | NBC Nightly News  NBC News
  3. Health officials: E. coli outbreak possibly tied to Evergreens Salad restaurants  Q13 News Seattle
  4. CDC reports 67 cases of E. coli linked to Salinas romaine lettuce  kion546.com
  5. Opinion: The Salinas lettuce recall is what happens with a rollback of food safety rules  Los Angeles Times
  6. View full coverage on Google News


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November 27, 2019 at 04:39PM Food Safety Tips for Healthy Holidays

Following these safe food-handling practices will help prevent foodborne illness.

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November 27, 2019 at 03:53PM No es demasiado tarde para vacunarse contra la gripe

¿Cree que es demasiado tarde para vacunarse contra la gripe? No lo es. Averigua por qué.

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Tuesday, November 26, 2019

November 26, 2019 at 07:35PM Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.

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November 26, 2019 at 08:15PM Center for Biologics Evaluation and Research Patient Engagement Program

Patient input is a critical part of CBER’s understanding of diseases and conditions. Engaging with patients and listening to their perspectives on their diseases and treatments may help the center advance patient-focused medical product development.

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November 26, 2019 at 07:35PM Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.

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November 26, 2019 at 07:10PM 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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November 26, 2019 at 03:25PM Now’s Still a Good Time to Get Your Flu Vaccine

Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one.

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November 26, 2019 at 03:25PM Now’s Still a Good Time to Get Your Flu Vaccine

Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one.

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Monday, November 25, 2019

November 25, 2019 at 08:20PM Innovation and Regulatory Science

Innovation and Regulatory Science

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November 25, 2019 at 08:58PM FDA Zika virus reference panel for molecular-based diagnostic devices supports product testing for Emergency Use Authorization and 510(k) submissions

Summary of research article for posting on CBER Innovation web site

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November 25, 2019 at 07:56PM Medical Countermeasure Monitoring and Assessment

FDA guidance and regulatory information, specific FDA projects related to monitoring and assessment of MCMs, ongoing FDA work related to medical product assessment in general, and key efforts relevant to MCM monitoring and assessment outside of FDA

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November 25, 2019 at 06:22PM Section 8400: Marketing Applications

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

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November 22, 2019 at 05:25PM UN Climate Change Conference - COP25

With the participation of CIRAD.



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November 19, 2019 at 12:36PM Paris International Agricultural Show

With the participation of CIRAD.



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November 25, 2019 at 11:36AM Dynamique des élevages pastoraux et agropastoraux en Afrique intertropicale

L’élevage réduit la vulnérabilité de nombreuses familles vivant proches du seuil de pauvreté. Un ouvrage décrit la dynamique des élevages en Afrique intertropicale, les différents systèmes rencontrés en zones arides et subhumides. Il aborde les impacts locaux et globaux des élevages sur l’environnement et souligne leur rôle socio-économique majeur.



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Friday, November 22, 2019

E. coli outbreak reported in romaine lettuce harvested from Salinas, California, CDC and FDA say - CNN

E. coli outbreak reported in romaine lettuce harvested from Salinas, California, CDC and FDA say  CNNView full coverage on Google News

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November 22, 2019 at 08:53PM Certificates of Confidentiality

Certificates of Confidentiality: Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff

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November 22, 2019 at 05:25PM Conférence internationale sur le climat - COP 25

Avec la participation du Cirad.



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November 22, 2019 at 05:26PM Remarks by Anna Abram to the Biocom Celebration of Life Dinner - 11/21/2019

Remarks by Anna Abram
Biocom Celebration of Life Dinner
La Jolla, CA
Nov. 21, 2019


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November 22, 2019 at 04:16PM 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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November 22, 2019 at 03:41PM BIMO/Team Biologics/Internet Surveillance/Other

This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

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November 18, 2019 at 04:27PM An alternative to antibiotics: protecting against bacteria rather than tackling them head-on

Antibiotic resistance kills 700 000 people worldwide each year. By 2050, the figure could be 10 million a year. To avoid such a catastrophic scenario, researchers from CIRAD in Guadeloupe are working with their partners* to determine how bacteria attack cells. The aim is to find ways of rendering pathogenic bacteria ineffective wihout using antibiotics. The disease the researchers are working on is cowdriosis, a disease caused by the Ehrlichia ruminantium bacterium that kills ruminants in the tropics.



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Thursday, November 21, 2019

November 21, 2019 at 02:25PM 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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November 14, 2019 at 03:40PM SARA | CIRAD and AFD are working towards a sustainable, innovative African agricultural modeldèle agricole africain durable et innovant

France will be centre stage at the Salon international de l’Agriculture et des Ressources Animales in Abidjan, Ivory Coast, from 22 November to 1 December. CIRAD and AFD will be welcoming visitors on a shared stand in the France Pavilion, and contributing to a series of round tables on the topic of sustainable, innovative farming systems that are also resilient to climate change.



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Tuesday, November 19, 2019

November 19, 2019 at 08:23PM 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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November 19, 2019 at 04:26PM Menactra

Product approval information for the Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine also known as Menactra

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November 19, 2019 at 12:36PM Salon international de l'agriculture de Paris

Avec la participation du Cirad.



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Monday, November 18, 2019

November 18, 2019 at 09:23PM PHS Guideline on Infectious Disease Issues in Xenotransplantation

This is the PHS Guideline on Infectious Disease Issues in Xenotransplantation, CBER, Biologics

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November 18, 2019 at 06:32PM TRUMENBA

Indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.

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November 18, 2019 at 03:52PM Is It a Cold or the Flu? Prevention, Symptoms, Treatments

How to tell if you have a cold or the flu, and when to seek medical care.

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November 18, 2019 at 04:27PM Alternative aux antibiotiques : se protéger des bactéries sans les attaquer de front

L’antibiorésistance tue 700 000 personnes par an à travers le monde. En 2050, elle pourrait en tuer 10 millions par an. Pour éviter ce scénario catastrophe, des chercheurs du Cirad de Guadeloupe et leurs partenaires* étudient comment les bactéries attaquent les cellules. L’objectif : trouver des moyens de rendre ces bactéries pathogènes inefficaces sans utiliser d’antibiotiques. La maladie dans le viseur des scientifiques est la cowdriose, une maladie mortelle pour les ruminants des régions tropicales et causée par la bactérie Ehrlichia ruminantium.



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November 18, 2019 at 03:52PM Is It a Cold or the Flu? Prevention, Symptoms, Treatments

How to tell if you have a cold or the flu, and when to seek medical care.

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Friday, November 15, 2019

November 16, 2019 at 12:29AM Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

FDA has taken another step to further foster biologics competition with the approval of 25th biosimilar, Abrilada (adalimumab - afzb), a biosimilar to Humira.

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November 15, 2019 at 06:52PM Measles, Mumps and Rubella Virus Vaccine, Live

Product approval information for the Measles, Mumps, and Rubella Virus Vaccine, Live also known as M-M-R II.

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November 15, 2019 at 05:50PM FluMist Quadrivalent

For active immunization of individuals 2 through 49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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November 15, 2019 at 04:14PM Quand l’intelligence artificielle optimise la lutte biologique contre les ravageurs

Réguler les ennemis des cultures par leurs prédateurs naturels nécessite d’identifier précisément leurs interactions. Tel est l’objectif du dispositif de reconnaissance Corigan développé par des chercheurs du Cirad, une approche inédite d’intelligence artificielle pour étudier les communautés d’insectes. La méthode, testée avec succès au Costa-Rica, associe un système de détection visuelle issu de l’apprentissage profond (Deep learning).



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November 08, 2019 at 03:56PM The roadmap for the Ouagadougou Declaration has been adopted

On 22 and 23 October 2019 in Niamey, the AGRHYMET regional centre, an institution of the Comité Inter-États de Lutte contre la Sécheresse au Sahel (CILSS), played host to the main players* working for the development of the Sahel countries that signed the Ouagadougou Declaration, including CIRAD. The seminar, organized by the Institut du Sahel , served to co-construct the roadmap for implementation of the Declaration over the coming year.



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Thursday, November 14, 2019

November 14, 2019 at 11:50PM Remarks by Anna Abram to the Food Allergy Summit - 11/14/2019

Remarks by Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs, to the Food Allergy Summit in Washington, DC on November 14, 2019

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November 14, 2019 at 10:02PM Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

For active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine.

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November 14, 2019 at 03:40PM SARA | Le Cirad et l’AFD se mobilisent pour promouvoir un modèle agricole africain durable et innovant

La France sera le pays à l’honneur du Salon international de l’Agriculture et des Ressources animales d’Abidjan en Côte d’Ivoire du 22 novembre au 1er décembre. Le Cirad et l’AFD accueilleront les visiteurs sur un stand commun sur le Pavillon France et contribueront à une série de tables rondes sur la thématique d’une agriculture durable, innovante et résiliente au changement climatique.



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November 14, 2019 at 01:56PM Changement climatique, gestion durable des terres et sécurité alimentaire

En partenariat avec le Cirad, l’association Météo et Climat consacre sa 12e Journée Scientifique à un décryptage du rapport spécial du Giec sur le changement climatique, l’usage des terres et la sécurité alimentaire.



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Wednesday, November 13, 2019

November 13, 2019 at 09:50PM Animal Rule Information

Links to information about the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible

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November 13, 2019 at 07:00PM Rotarix

Rotarix approval page indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9), for use in infants 6 weeks to 24 weeks of age.

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November 13, 2019 at 07:11PM Fluzone, Fluzone High-Dose and Fluzone Intradermal

Product approval information for Human Papillomavirus 9-valent Vaccine, Recombinant.

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Two Cases of Pneumonic Plague in China Spark Fears of an Outbreak - Slate

  1. Two Cases of Pneumonic Plague in China Spark Fears of an Outbreak  Slate
  2. Two people just got the plague in China — yes, the Black Death plague  CNN
  3. Plague outbreak: China hit by ‘highly contagious’ pneumonic plague - what are symptoms?  Express.co.uk
  4. Two people in China diagnosed with pneumonic plague | TheHill  The Hill
  5. Two patients diagnosed with plague in China as officials scramble to prevent outbreak  New York Post
  6. View full coverage on Google News


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November 13, 2019 at 05:44PM Fluvirin

For active immunization of persons 4 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

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November 13, 2019 at 04:58PM Entreprendre contre la malnutrition

Colloque organisé par la Fondation Avril dans le cadre du Salon international de l'agriculture et des ressources animales d'Abidjan. En partenariat avec le Cirad.



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November 13, 2019 at 03:17PM Devices Guidances

This page lists Medical Device Guidance documents.

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Two Cases of Pneumonic Plague in China Sparks Fears of an Outbreak - Slate

  1. Two Cases of Pneumonic Plague in China Sparks Fears of an Outbreak  Slate
  2. Two people just got the plague in China — yes, the Black Death plague  CNN
  3. Two patients diagnosed with plague in China as officials scramble to prevent outbreak  New York Post
  4. Two people diagnosed with pneumonic plague in China  The Guardian
  5. Two people from China-Mongolia border are infected with plague  Daily Mail
  6. View full coverage on Google News


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November 13, 2019 at 02:11PM FluLaval Quadrivalent

For active immunization of persons 6 months 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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November 13, 2019 at 01:50PM FluLaval

Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLULAVAL is approved for use in persons 6 months of age and older.

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Tuesday, November 12, 2019

November 12, 2019 at 09:53PM 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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November 12, 2019 at 09:39PM FLUCELVAX

For active immunization of persons 4 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

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November 12, 2019 at 06:33PM Fluarix Quadrivalent

For active immunization of persons 6 months 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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November 12, 2019 at 04:49PM Fluarix

For active immunization against influenza for individuals 3 years of age or older and to include the data from pediatric clinical studies with revision of the prescribing information.

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November 12, 2019 at 03:56PM Strong Fertility Center - 593262 - 10/29/2019

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

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November 12, 2019 at 11:53AM Journées rurales 2020

Organisées par le collectif Agricités sur le thème : Les relations villes-campagnes face à la question alimentaire. En partenariat avec le Cirad.



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November 12, 2019 at 11:12AM Recherche & Innovation : quels leviers pour le développement des Outre-mer ?

Une conférence organisée par l'AFD, l'IRD et le Cerom, avec la participation du Cirad.



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November 12, 2019 at 11:03AM CARI 2020

Le colloque Africain sur la Recherche en Informatique en en mathématique appliqué est co-organisé par l’Agence Universitaire de la Francophonie (AUF), le Cirad, le Centre International des Mathématiques Pures et Appliquées (CIMPA), l’Inria et l’IRD.



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Saturday, November 9, 2019

Air from Siberia to send temperatures plunging from Texas to New England - The Guardian

  1. Air from Siberia to send temperatures plunging from Texas to New England  The Guardian
  2. Arctic outbreak to bring near-record November cold and inches of snow  WXMI FOX 17 West Michigan
  3. Like January in November: Much of US braces for record lows  WSAZ-TV
  4. Record Cold Expected in Chicago Next Week  NBC Chicago
  5. Approaching cold front could set record lows in much of US  WAOW
  6. View full coverage on Google News


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Chilly down to the Gulf of Mexico: What you should know about the arctic blast - USA TODAY

  1. Chilly down to the Gulf of Mexico: What you should know about the arctic blast  USA TODAY
  2. Winter is coming: Arctic blast could shatter 190 or more record-cold temperatures across the US, meteorologists say  FOX 11 Los Angeles
  3. Arctic outbreak to bring near-record November cold and inches of snow  WXMI FOX 17 West Michigan
  4. Next week's Arctic blast will be so cold, forecasters expect it to break 170 records across US  msnNOW
  5. Upcoming Arctic blast expected to break temperature records nationwide  Kewanee Star Courier
  6. View full coverage on Google News


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Friday, November 8, 2019

November 08, 2019 at 08:23PM CPG Sec. 110.100 Certification for Exports

CPG Sec. 110.100 Certification for Exports

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November 08, 2019 at 08:09PM 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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November 08, 2019 at 04:44PM 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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November 08, 2019 at 03:56PM La feuille de route de la Déclaration de Ouagadougou adoptée

Le Centre Régional Agrhymet, institution du Comité Inter-États de Lutte contre la Sécheresse au Sahel (CILSS), a accueilli les 22 et 23 octobre 2019 à Niamey, les principaux acteurs* œuvrant au développement des pays sahéliens et signataires de la Déclaration de Ouagadougou, dont le Cirad. Ce séminaire, organisé par l’Institut du Sahel, a permis de co-construire la feuille de route de la mise en œuvre de cette Déclaration pour l’année à venir.



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November 08, 2019 at 04:43PM 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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November 08, 2019 at 04:08PM 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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November 08, 2019 at 03:20PM Flublok Quadrivalent

Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older.

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Thursday, November 7, 2019

November 07, 2019 at 09:44PM 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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November 07, 2019 at 07:49PM Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement - 09/13/2019 - 09/13/2019

This is the main page for the Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement.

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November 07, 2019 at 07:30PM Vaccines and Related Biological Products Advisory Committee October 9, 2019 Meeting Announcement - 10/09/2019 - 10/09/2019

This is the CBER Vaccines and Related Biological Products Advisory Committee October 9, 2019 Meeting Announcement.

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November 07, 2019 at 07:22PM Blood Products Advisory Committee March 20 - 21, 2019 Meeting Announcement - 03/20/2019 - 03/21/2019

This is the CBER Blood Products Advisory Committee March 20 - 21, 2019 Meeting Announcement.

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November 07, 2019 at 07:14PM 2018 Meeting Materials, Blood Products Advisory Committee

This is the main page for the 2018 Meeting Materials, Blood Products Advisory Committee.

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November 07, 2019 at 07:13PM July 18-19, 2018: Blood Products Advisory Committee Meeting Announcement - 07/17/2018 - 07/18/2018

This is the Meeting Announcement for the July 18-19, 2018, Blood Products Advisory Committee (BPAC) Meeting.

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November 07, 2019 at 06:05PM 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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November 07, 2019 at 04:51PM FDA Voices on Policy

FDA Voices on Policy

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November 07, 2019 at 04:09PM Patient Perspective Is Vital to FDA's Work

FDA considers patients the real experts when it comes to their own health condition. Rare disease patient listening sessions are one more way FDA is engaging patients in all of the steps of the discovery and development process for medical products.

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November 07, 2019 at 03:57PM Cleared 510(k) Submissions with Supporting Documents - 2019

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

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November 07, 2019 at 03:29PM Collection of Race and Ethnicity Data in Clinical Trials

Guidance for Industry and FDA Staff - Collection of Race and Ethnicity Data in Clinical Trials

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Wednesday, November 6, 2019

November 06, 2019 at 09:44PM Medical Device Cybersecurity: What You Need to Know

Practice vigilance to safeguard your medical devices from cyber threats.

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November 06, 2019 at 09:38PM Tobacco Products

Tobacco comes in many forms, from cigars and cigarettes to smokeless tobacco and dissolvable nicotine products. FDA works to reduce the use of these products, and the harm that they cause. To learn more read these Consumer Updates.

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November 06, 2019 at 09:31PM Medical Devices

Consumer articles about medical devices.

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November 06, 2019 at 09:10PM Food

Timely articles and multimedia content about food and food-safety.

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November 06, 2019 at 09:07PM Drugs

Consumer articles about over-the-counter and prescription drugs.

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November 06, 2019 at 09:03PM Dietary Supplements

Dietary supplements are regulated by the FDA as food, not as drugs. However, many dietary supplements contain ingredients that have strong biological effects which may conflict with a medicine you are taking or a medical condition you may have. Products containing hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at greater risk. For these reasons, it is important to consult with a health care professional before using any dietary supplement. Read these Consumer Updates to learn more.

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November 06, 2019 at 08:59PM Cosmetics

Consumer articles about cosmetics.

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November 06, 2019 at 07:58PM 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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November 06, 2019 at 09:33PM INFANRIX

Product approval information for Diphtheria Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed also known as Infanrix.

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November 06, 2019 at 12:39PM BR190330 - Sentosa SQ HIV-1 Genotyping Assay

A next generation sequencing-based in vitro diagnostic test intended for use in detecting HIV-1 genomic mutations (in the protease, reverse transcriptase and integrase regions of the pol gene) as an aid in monitoring and treating HIV-1 infection.

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Tuesday, November 5, 2019

November 05, 2019 at 10:14PM Sentosa SQ HIV-1 Genotyping Assay

• The Sentosa SQ HIV-1 Genotyping Assay is a next generation sequencing (NGS)-based in vitro diagnostic (IVD) test intended for use in detecting HIV-1 genomic mutations (in the protease, reverse transcriptase and integrase regions of the pol gene), as an aid in monitoring and treating HIV-1 infectio

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November 05, 2019 at 09:17PM Sentosha SQ HIV-1 Genotyping Assay

• The Sentosa SQ HIV-1 Genotyping Assay is a next generation sequencing (NGS)-based in vitro diagnostic (IVD) test intended for use in detecting HIV-1 genomic mutations (in the protease, reverse transcriptase and integrase regions of the pol gene), as an aid in monitoring and treating HIV-1 infectio

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November 05, 2019 at 05:08PM Procleix Ultrio Plus Assays

Product approval information for:
•Use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors.
•Use in testing individual samples from living donors of whole blood, blood components, or source plasma, other living donors and heart-beating organ donors, and for testing individual blood specimens from cadaveric (non-heart-beating) donors.
•Use in testing pools of human plasma comprised of equal aliquots of not more than 16 individual donations from donors of whole blood, blood components, or source plasma.

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November 05, 2019 at 01:40PM Tissue Establishment Registration

Establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service (PHS) Act are required to register with FDA pursuant to 21 CFR Part 1271. Also, provided information on when to register update regist

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Monday, November 4, 2019

November 04, 2019 at 10:05PM Fluzone High-Dose Quadrivalent

For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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November 04, 2019 at 09:48PM Section 8100: Communication

This is the CBER SOPP Section 8100: Communication main page.

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November 04, 2019 at 09:22PM CUVITRU

Product approval information is indicated for replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.

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November 01, 2019 at 10:16PM Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases

Testing HCT/P Donors for Relevant Communicable Diseases

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