Trump refuses to lead as pandemic worsens and allies desert him on masks - CNN

1. Trump refuses to lead as pandemic worsens and allies desert him on masks  CNN
2. GOP-Trump fractures on masks open up | TheHill  The Hill
3. Republican leaders now say everyone should wear a mask — even as Trump refuses and has mocked some who do  The Washington Post
4. Florida’s coronavirus outbreak complicates Republican convention, Trump’s reelection bid  Miami Herald
5. Senate Republicans distance themselves from Trump on coronavirus masks  NBC News
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June 30, 2020 at 11:55PM Studying the Structure of Carbohydrates in Order to Better Understand Bacterial Vaccines and Pathogens

A description of John Cipollo's research program and related publications.

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Fauci warns Congress that new US coronavirus cases could rise to 100,000 a day - CNN

1. Fauci warns Congress that new US coronavirus cases could rise to 100,000 a day  CNN
2. Dr. Anthony Fauci says U.S. coronavirus outbreak is 'going to be very disturbing,' could top 100,000 new cases a day  CNBC
3. Fauci warns US could see 100,000 coronavirus cases a day if surge continues  Fox News
4. Fauci, Redfield testify on Covid-19 reopening: Live updates  CNN
5. Fauci warns there could be up 100000 new cases of coronavirus per day  Washington Post
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June 30, 2020 at 11:47PM Safety and Effectiveness of Gene Therapy

A description of Andrew Byrnes' research program and related publications.

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June 30, 2020 at 11:37PM Evaluating New Approaches to Developing AIDS Vaccines by Creating Virus-like Particles that Display HIV Antigens or by Using Live, Attenuated (Weakened), non-HIV Viruses to Express HIV Proteins

A description of Ira Berkower's research program and related publications.

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June 30, 2020 at 10:35PM Coronavirus (COVID-19) Update: Daily Roundup June 30, 2020

Coronavirus (COVID-19) Update: Daily Roundup

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Dr. Anthony Fauci says U.S. coronavirus outbreak is 'going to be very disturbing,' could top 100,000 new cases a day - CNBC

Dr. Anthony Fauci says U.S. coronavirus outbreak is 'going to be very disturbing,' could top 100,000 new cases a day  CNBCView Full Coverage on Google News

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Dr. Anthony Fauci says U.S. coronavirus outbreak is 'going to be very disturbing,' could top 100,000 new cases a day - CNBC

1. Dr. Anthony Fauci says U.S. coronavirus outbreak is 'going to be very disturbing,' could top 100,000 new cases a day  CNBC
2. Fauci, Redfield testify on Covid-19 reopening: Live updates  CNN
3. Live Coronavirus News Updates  The New York Times
4. Fauci issues grim warning: 'No guarantee' of a safe, effective vaccine  Fox News
5. California, Texas see record COVID-19 surges, Arizona clamps down  Reuters UK
6. View Full Coverage on Google News

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June 30, 2020 at 05:43PM Evaluation of Therapeutic Approaches Based on Genome Editing and Stem Cell Technologies

Zhaohui Ye's research project "Evaluation of Therapeutic Approaches Based on Genome Editing and Stem Cell Technologies".

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June 30, 2020 at 04:41PM Vaccine and Related Biological Product Guidances

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

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June 30, 2020 at 04:41PM Development and Licensure of Vaccines to Prevent COVID-19

This is the Guidance for Industry, Development and Licensure of Vaccines to Prevent COVID-19, CBER, Biologics

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June 29, 2020 at 06:07PM Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking

This guidance describes FDA's intention with regard to enforcement of requirements for class I and unclassified devices.

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June 25, 2020 at 02:47PM West Africa | 40 000 producers will benefit from a new European plant breeding project

Plant breeding is a key challenge for resilience to climate change among agricultural producers. A new far-reaching project is aimed at strengthening networks and institutional capacities in this field in three West African countries. With almost 9 million euros of funding, it is coordinated by CORAF and implemented by a consortium of national and international institutes, including CIRAD, within the framework of DeSIRA, the major EU funding programme.

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June 29, 2020 at 09:30PM How You Can Make a Difference During the Coronavirus Pandemic

The COVID-19 pandemic has caused challenges in our everyday lives. Here are some ways we can all do our part to help slow the spread of coronavirus disease.

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June 29, 2020 at 06:46PM For Consumers: Seven Things Pregnant Women and Parents Need to Know About Arsenic in Rice and Rice Cereal

You may be surprised to learn that there is arsenic found in rice. FDA is taking steps to protect consumers and reduce the amount in infant rice cereal.

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WHO warns coronavirus pandemic is speeding up as countries ease lockdown rules: 'The worst is yet to come' - CNBC

1. WHO warns coronavirus pandemic is speeding up as countries ease lockdown rules: 'The worst is yet to come'  CNBC
2. WHO director: Pandemic 'speeding up' | TheHill  The Hill
3. Pandemic 'is not even close to being over', WHO chief says  Reuters
4. Watch live: World Health Organization holds press conference on the coronavirus outbreak  CNBC
5. WHO boss says COVID-19 'not even close to being over' & virus is 'speeding up'  The Sun
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June 29, 2020 at 06:08PM Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

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

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June 29, 2020 at 03:29PM Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry

Guidance for Industry: Drug Safety

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June 29, 2020 at 02:54PM Development of Anti-Infective Drug Products for the Pediatric Population

Pediatric Drug Products

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Global COVID-19 Deaths Top 500,000 : Coronavirus Live Updates - NPR

1. Global COVID-19 Deaths Top 500,000 : Coronavirus Live Updates  NPR
2. Global cases of coronavirus exceed 10 million  Reuters
3. Coronavirus cases worldwide top 10 million with nearly half a million deaths — and 25% are in the US  CNBC
4. Coronavirus Live Updates: Global Deaths Pass 500,000  The New York Times
5. Coronavirus Outbreak: Live Updates and News for June 29, 2020  Bloomberg
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As U.S. soars past 2.5 million coronavirus cases, Pence urges Americans to wear masks, social distance - The Washington Post

1. As U.S. soars past 2.5 million coronavirus cases, Pence urges Americans to wear masks, social distance  The Washington Post
2. Pence commits resources after Texas governor notes coronavirus outbreak's 'very swift and very dangerous turn'  Fox News
3. Choir of more than 100 people perform without masks at Pence event  CNN
4. As Texas coronavirus cases surge, VP Mike Pence attends megachurch service  AOL
5. Pence In Texas Encourages Residents To Wear Masks Amid Coronavirus Spike | NBC Nightly News  NBC News
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Choir of more than 100 people perform without masks at Pence event - CNN

1. Choir of more than 100 people perform without masks at Pence event  CNN
2. Pence commits resources after Texas governor notes coronavirus outbreak's 'very swift and very dangerous turn'  Fox News
3. Pence on Black Lives Matter: "I really believe all lives matter"  Face the Nation
4. As coronavirus cases set new records, the positivity rate becomes a political football  Salon
5. Pence: Masks 'Good Idea' When Distancing Not Possible | NBC News  NBC News
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'We have to act' — HHS Secretary Azar warns 'window closing' to halt coronavirus spike - CNBC

1. 'We have to act' — HHS Secretary Azar warns 'window closing' to halt coronavirus spike  CNBC
2. Only two US states are reporting a decline in new coronavirus cases  CNN
3. Florida adds another 8,530 confirmed COVID-19 cases. Miami-Dade hits single-day high  Miami Herald
4. California orders some bars to close as U.S. posts record COVID cases  Reuters
5. Pence commits resources after Texas governor notes coronavirus outbreak's 'very swift and very dangerous turn'  Fox News
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Bagged salad recall expands to Walmart amid cyclospora outbreak - WIS10

Bagged salad recall expands to Walmart amid cyclospora outbreak  WIS10View Full Coverage on Google News

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Gov. Cuomo complains of 'political heat' over coronavirus nursing home deaths - New York Post

1. Gov. Cuomo complains of 'political heat' over coronavirus nursing home deaths  New York Post
2. Families of NYPD shooting victims slam Governor Cuomo  CBS News
3. Cuomo: Trump administration 'in denial' about coronavirus 'problem' | TheHill  The Hill
4. De Blasio's performance grows worse by the day, making NYC unlivable: Goodwin  New York Post
5. Cuomo says NY to probe coronavirus outbreak in town after student visits Florida  Fox News
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Bagged salad recall expands to Walmart amid cyclospora outbreak - WIS10

Bagged salad recall expands to Walmart amid cyclospora outbreak  WIS10View Full Coverage on Google News

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NY student sparks COVID-19 cluster after returning from Florida - New York Post

1. NY student sparks COVID-19 cluster after returning from Florida  New York Post
2. New York to investigate potential coronavirus cluster from graduation after Florida traveler tests positive  CNBC
3. Cuomo says NY to probe coronavirus outbreak in town after student visits Florida  Fox News
4. NY probing Westchester graduation with COVID-19 positive guest  New York Daily News
5. Coronavirus and Cuomo: The governor had it right back when he opposed quarantines | Mulshine  NJ.com
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Walmart, Aldi recall salad mixes due to cyclospora - WFLA

1. Walmart, Aldi recall salad mixes due to cyclospora  WFLA
2. More than 200 people get infections linked to bagged salad sold in eight states  CNN
3. RECALL: Hy-Vee recalls salads due to possible Cyclospora bacteria  week.com
4. Hy-Vee recalls more bagged salad because of possible contamination  KMBC 9
5. Walmart, Aldi recall some Fresh Express garden salad mixes potentially linked to growing Cyclospora outbreak  Palm Beach Post
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Coronavirus cases surge as pressure mounts on healthcare workers - CBS Evening News

1. Coronavirus cases surge as pressure mounts on healthcare workers  CBS Evening News
2. How to Watch, Live-Stream Friday White House Coronavirus Briefing  Newsweek
3. Fact check: As pandemic situation worsens, Pence paints a deceptively rosy picture  CNN
4. Fauci pleads with Americans to do their part to curb coronavirus outbreak | TheHill  The Hill
5. White House coronavirus task force holds briefing as cases spike  CBS News
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Walmart, Aldi recall some Fresh Express garden salad mixes potentially linked to growing Cyclospora outbreak - USA TODAY

Walmart, Aldi recall some Fresh Express garden salad mixes potentially linked to growing Cyclospora outbreak  USA TODAYView Full Coverage on Google News

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WHO warns of coronavirus summer spike as Europe lifts lockdown - NBC News

1. WHO warns of coronavirus summer spike as Europe lifts lockdown  NBC News
2. World Health Organization warns of COVID resurgence in Europe  ABC News
3. ‘Significant Resurgence’ Narrows Europe’s Coronavirus Gap With U.S.—But Americans Probably Still Can’t Visit  Forbes
4. Europe sees 'significant resurgence' of coronavirus after lockdowns lifted  New York Post
5. WHO Sounds Alarm on Resurgence in Europe’s Coronavirus Outbreak  U.S. News & World Report
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June 26, 2020 at 11:33PM Developing Tests to Detect Evidence of Protective Immune Responses Generated by Vaccines for Respiratory Viruses That Infect Infants, Children and the Elderly

A description of Judy Beeler's research program and related publications.

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June 26, 2020 at 11:21PM Development of strategies to improve cell therapy product characterization

A description of Steven Bauer's research program and related publications.

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June 26, 2020 at 10:55PM Biomarkers of Vaccine Safety and Effectiveness for Encapsulated Bacterial Pathogens

A description of Margaret Bash's research program and related publications.

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June 26, 2020 at 10:16PM Medical Product Purity: Maintaining Biologics and Other FDA-regulated Products Free of the Infectious Agents of Transmissible Spongiform Encephalopathies (TSE Agents or Prions)

A description of David Asher's research program and related publications.

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June 26, 2020 at 10:10PM Evaluating the Safety and Efficacy of Hemoglobin-based Blood Substitutes

The development of a safe and effective blood substitute would greatly improve the emergency treatment of accident victims and wounded soldiers, as well as patients undergoing cardiac surgery, especially when whole blood is in short supply.

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June 26, 2020 at 10:04PM Evaluating the Host and Microbial Factors That Impact the Efficacy of Polysaccharide Vaccines

A description of Mustafa Akkoyunlu's research program and related publications.

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June 26, 2020 at 08:56PM BeneFIX

Product approval information is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease)

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June 26, 2020 at 08:30PM Patient Engagement Collaborative

The Patient Engagement Collaborative (PEC) is an advancement in FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Patient Affairs Staff (PAS) in the Office of Clinical Policy and Programs (OCPP).

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June 26, 2020 at 04:41PM Review and Update of Device Establishment Inspection Processes and Standards

Guidance for Industry: Review and Update of Device Establishment Inspection Processes and Standards

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June 26, 2020 at 03:28PM Review and Update of Device Establishment Inspection Processes and Standards

Draft guidance for industry: Review and Update of Device Establishment Inspection Processes and Standards

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No turning back for Florida, Texas? The next two weeks are 'critical' for US, Fauci warns - USA TODAY

1. No turning back for Florida, Texas? The next two weeks are 'critical' for US, Fauci warns  USA TODAY
2. Coronavirus Outbreak: Live Updates and News for Jun. 26, 2020  Bloomberg
3. Doctor says states should consider going into lockdown again as COVID cases rise  CBS News
4. Column: As coronavirus cases surge, don’t blame Trump. Nobody could have predicted a highly contagious virus w  Chicago Tribune
5. Florida, Texas, Arizona face hurdles in getting outbreaks under control | TheHill  The Hill
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June 25, 2020 at 11:47PM 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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June 25, 2020 at 10:04PM 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 drug 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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June 23, 2020 at 07:25PM Facts About In-Home HIV Testing

HIV can be controlled. The first step is getting tested. An FDA-approved home test is one option.

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June 23, 2020 at 07:25PM Facts About In-Home HIV Testing

HIV can be controlled. The first step is getting tested. An FDA-approved home test is one option.

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June 25, 2020 at 07:02PM Consumers (Biologics)

Resources for consumers on biological products.

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June 25, 2020 at 05:29PM Partnering with the European Union and Global Regulators on COVID-19

The FDA and the European Commission (EC) and its European Medicines Agency (EMA) are collaborating on many scientific and regulatory fronts as part of our COVID-19 response.

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Texas has a "massive" coronavirus outbreak across the state after reopening, governor says - CBS News

1. Texas has a "massive" coronavirus outbreak across the state after reopening, governor says  CBS News
2. Why Six Critically Ill Covid-19 Patients Would Overwhelm This Texas Hospital | NYT Opinion  The New York Times
3. Texas Covid-19 cases hit all-time daily high as Houston hospitals near capacity  The Guardian
4. Covid-19 Gives Texas a Reality Check  Bloomberg
5. Pretending coronavirus doesn't exist won't make it go away  Los Angeles Times
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June 25, 2020 at 03:33PM CPG 230.120- Human Blood and Blood Products as Drugs

CPG 230.120- Human Blood and Blood Products as Drugs

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June 25, 2020 at 03:31PM CPG Sec. 270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting Changes

CPG Sec. 270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting Changes

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June 25, 2020 at 02:47PM Afrique de l’Ouest | 40 000 producteurs bénéficieront d’un nouveau projet européen de sélection végétale

L’amélioration des plantes constitue un enjeu de taille pour la résilience des producteurs et productrices agricoles face au changement climatique. Un nouveau projet d’envergure a pour objectif de renforcer les réseaux et les capacités institutionnelles de trois pays d’Afrique de l’Ouest dans ce domaine. Doté d’un financement de près de 9 millions d’euros, il est coordonné par le Coraf, mis en œuvre par un consortium d’instituts nationaux et internationaux dont le Cirad, dans le cadre du grand programme de financement DeSIRA de l’Union européenne.

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June 25, 2020 at 02:23PM Development & Approval Process (CBER)

Key resources and information related to CBER development & approval process.

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Virus Cases Are Soaring in Texas. But Closing Down Again Is a ‘Last Option.’ - The New York Times

1. Virus Cases Are Soaring in Texas. But Closing Down Again Is a ‘Last Option.’  The New York Times
2. Texas governor says there is a "massive" coronavirus outbreak across the state after reopening  CBS News
3. Texas Gov. Abbott: State-run coronavirus testing sites will give free masks to everyone tested as cases spike  Fox News
4. Texas hits all-time high for COVID-19 cases; governor urges residents to stay home  USA TODAY
5. Governor Says Texas Has 'Massive' Outbreak As New Cases Again Exceed 5,000  Newsweek
6. View Full Coverage on Google News

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June 25, 2020 at 10:11AM Adhésion de la France au programme PRC-BIO de l’OCDE : de nouveaux financements pour accroître la coopération scientifique à l’international

Sécurité alimentaire, impact du changement climatique, gestion des ressources naturelles, autant de défis à relever qui doivent s’appuyer sur une plus grande coopération scientifique internationale. Après 8 années de suspension, la France, représentée par les ministères en charge de l’agriculture et de la recherche, avec l’appui d’INRAE, du Cirad et d’Agreenium, reviendra en 2021 au sein du Programme de Recherche en Collaboration (PRC) de l'Organisation de coopération et de développement économiques (OCDE) pour travailler notamment sur la gestion des ressources naturelles pour des systèmes agricoles durables. Les appels à candidatures sont ouverts dès à présent pour les acteurs de la recherche en France souhaitant obtenir des parrainages de conférences ou des bourses de recherche pour 2021.

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Texas hospitalizations from coronavirus rise 60% in a week, governor calls spread "unacceptable" - CBS This Morning

1. Texas hospitalizations from coronavirus rise 60% in a week, governor calls spread "unacceptable"  CBS This Morning
2. 5489 New COVID-19 Cases: Texas Reports All-Time Daily High  NPR
3. Texas hits all-time high for COVID-19 cases; governor urges residents to stay home  USA TODAY
4. Texas governor says there is a "massive" coronavirus outbreak across the state after reopening  CBS News
5. Texas military bases contributed $123.6B to state economy, 630K jobs in 2019, officials say  Fox News
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June 24, 2020 at 06:12PM Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020

This is the list of guidance topics CBER is considering for development during Calendar Year 2020.

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June 24, 2020 at 04:12PM 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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June 23, 2020 at 10:21PM Improving the Safety of Blood and Blood Related Products by Reducing the Risk of Transfusion-Transmission of Leishmania Parasites

A description of Hira Nakhasi's research program and related publications.

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June 23, 2020 at 08:30PM Vascular Responses and Biological Product Safety and Efficacy

The main focus of this research program is to study the mechanisms by which biological products or pathogens alter the functioning or integrity of the vascular system in both vascular endothelial cell culture systems and animal models.

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June 23, 2020 at 08:20PM Characterization of Bacterial Glycoconjugates and Development of Associated Vaccine Technologies

A description of Willie Vann's research program and related publications.

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June 23, 2020 at 08:14PM Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement - 05/08/2020 - 05/08/2020

This is the main page for the CBER Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement.

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June 23, 2020 at 08:11PM Immunogenicity of Protein-based Therapeutics

A description of Zuben Sauna's research program and related publications.

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June 23, 2020 at 06:36PM Developing and Evaluating Animal Models for Studying the Safety and Efficacy of Vaccines Against Anthrax, Staphylococcal Infections, and Pertussis

A description of Tod Merkel's research program and related publications.

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June 23, 2020 at 06:35PM FDA Voices on Policy

FDA Voices on Policy

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June 23, 2020 at 06:25PM Safety and Efficacy of Immune Globulins and Alpha-1 Proteinase Inhibitors

A description of Dorothy Scott's research program and related publications.

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June 23, 2020 at 06:15PM Developing New Methods to Measure the Efficacy, Safety and Potency of Preventive and Therapeutic Vaccines Against Hepatitis Viruses

A description of Marian Major's research program and related publications.

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June 23, 2020 at 04:57PM Developing Predictive Indicators of Cell Maturation as Measures of Cell Therapy Product Efficacy and Safety

A description of Deborah Hursh's research program and related publications.

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June 23, 2020 at 04:51PM Improving Vaccine Manufacturing Evaluation for Bacterial Respiratory Pathogens

A description of Drusilla Burns' research program and related publications.

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June 23, 2020 at 04:43PM Transmissible Spongiform Encephalopathy Infectivity in Blood and Other Biologicals: Strategies for Detection, Decontamination and Removal

A description of Luisa Gregori's research program and related publications.

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June 23, 2020 at 02:45PM Getting Smarter about Food Safety: The Pandemic and Lessons Learned

Throughout the COVID-19 pandemic, the experts at the U.S. Food and Drug Administration have learned valuable lessons that will help shape our work to create a more digital, transparent and safer food system for you and your family.

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The giant meatpacking company at the heart of Germany's new coronavirus hotspot - CNN

1. The giant meatpacking company at the heart of Germany's new coronavirus hotspot  CNN
2. Germany scrambles to contain coronavirus outbreak at slaughterhouse; more than 1,300 infected  Fox News
3. Germany Imposes Local Lockdown After Virus Outbreak at Meat Plant  The New York Times
4. Germany imposes fresh lockdown after coronavirus outbreak at meat factory  CNN
5. Meat plant must be held to account for Covid-19 outbreak, says German minister  The Guardian
6. View Full Coverage on Google News

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June 19, 2020 at 11:46AM The bont-legged tick under surveillance

Since 2015, CIRAD has been studying the tick Hyalomma marginatum , which has been regularly observed along the Mediterranean coast in France. The exact origin of this species, which has been present in Corsica for several decades but has only recently arrived in mainland France, is still unknown. Unlike the species Ixodes ricinus, this tick is not a vector of the bacteria that causes Lyme disease. But it can transmit Crimean-Congo haemorrhagic fever, a virus that has not yet been detected in France.

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Coronavirus news: South Korea faces second wave as new Covid-19 cases rise - Vox.com

1. Coronavirus news: South Korea faces second wave as new Covid-19 cases rise  Vox.com
2. South Korea says it is battling 'second wave'  Reuters
3. Coronavirus cases surge in U.S. and Brazil as Germany reports more outbreaks, but markets don't seem worried  CNBC
4. Coronavirus: South Korea confirms second wave of infections  BBC News
5. WHO reports biggest one-day rise in coronavirus cases to date  CBS News
6. View Full Coverage on Google News

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June 22, 2020 at 10:12PM Vaccines

CBER regulates vaccine products. Vaccine information includes a listing of vaccines approved for marketing, questions about vaccines, vaccine safety and availability, and vaccine-related guidance documents, notices, and rules.

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Global coronavirus cases top 9 million as outbreak surges in Brazil, India - Reuters

1. Global coronavirus cases top 9 million as outbreak surges in Brazil, India  Reuters
2. WHO reports largest single-day increase in coronavirus cases  NBC News
3. WHO Announces Biggest Single Day Rise in COVID-19 Cases Globally  Newsweek
4. Coronavirus updates: Largest single-day increase in cases worldwide; university re-opening plans; bicycle trend  USA TODAY
5. Global number of coronavirus cases top 9 million: Live updates  Al Jazeera English
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June 22, 2020 at 06:02PM Recently Issued Guidance Documents

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

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June 22, 2020 at 06:00PM Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers

FDA is issuing this guidance to provide clarity on meetings and user fees during the COVID-19 public health emergency.

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June 22, 2020 at 05:50PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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Germany's coronavirus reproduction rate soars after massive outbreak at meat plant - CNN

1. Germany's coronavirus reproduction rate soars after massive outbreak at meat plant  CNN
2. Germany's coronavirus reproduction rate jumps above key containment level  CNBC
3. Coronavirus: Germany's R rate rockets to 2.88 amid fears of second wave - Business Insider  Business Insider
4. Germany’s Virus Infection Rate Driven Higher by Local Outbreaks  Bloomberg
5. Coronavirus cases surge in U.S. and Brazil as Germany reports more outbreaks, but markets don't seem worried  CNBC
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China Suspends Poultry Imports From Tyson Foods Plant In Arkansas - NPR

1. China Suspends Poultry Imports From Tyson Foods Plant In Arkansas  NPR
2. China Suspends Tyson Foods Poultry Imports From Arkansas Facility Following Outbreak  Forbes
3. The Latest: Israeli PM urges action to avoid more lockdowns  Sacramento Bee
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LSU football dealing with coronavirus outbreak to at least a quarter of its roster - The Washington Post

1. LSU football dealing with coronavirus outbreak to at least a quarter of its roster  The Washington Post
2. Sources: Large number of LSU football players placed in quarantine  ESPN
3. Tigerland bars temporarily close after employees test positive for COVID-19  LSU Tiger TV
4. OPINION: Will Louisiana wake up now that COVID-19 has hit LSU football?  Daily Advertiser
5. How Does Recent COVID-19 Outbreak Among LSU Football Players Affect Program Moving Forward?  Sports Illustrated
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China Reports More New COVID-19 Cases in Beijing Amid Second Wave Fears - Newsweek

1. China Reports More New COVID-19 Cases in Beijing Amid Second Wave Fears  Newsweek
2. China hopes testing will curb new coronavirus outbreak in Beijing  New York Post
3. Mainland China reports 26 new COVID-19 cases including 22 in Beijing  Reuters
4. In Beijing it looked like coronavirus was gone. Now we're living with a second wave  The Guardian
5. Beijing Cuts Mass Transit To Stop COVID-19 Outbreak | NBC News NOW  NBC News
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Hy-Vee recalls salad product after potential Cyclospora contamination - 1011now

1. Hy-Vee recalls salad product after potential Cyclospora contamination  1011now
2. Jewel-Osco Recalling Bagged Signature Farms Salad Over Cyclospora Concerns  CBS Chicago
3. FDA investigates illness linked to Hy-Vee, ALDI, Jewel-Osco salads  KCCI Des Moines
4. Hy-Vee Recalling 12 oz. Hy-Vee Brand Bagged Garden Salad Due To Possible Contamination  exploreokoboji.com
5. Jewel Osco Recalls Signature Farms Garden Salad Due To Cyclospora Outbreak  CBS Chicago
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At Least 30 LSU Football Players Quarantined Due to COVID-19 Outbreak - Sports Illustrated

1. At Least 30 LSU Football Players Quarantined Due to COVID-19 Outbreak  Sports Illustrated
2. Sources: Large number of LSU football players placed in quarantine  ESPN
3. LSU quarantines at least 30 football players  NBC Sports - NFL
4. Report: At least 30 LSU football players quarantined, some linked to Tigerland outbreak  WDSU New Orleans
5. Sources: Multiple LSU football players have tested positive for coronavirus and are in quarantine  The Advocate
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FDA issues warning for Aldi, Hy-Vee bagged garden salad products - KCRG

1. FDA issues warning for Aldi, Hy-Vee bagged garden salad products  KCRG
2. Jewel Osco Recalls Signature Farms Garden Salad Due To Cyclospora Outbreak  CBS Chicago
3. Bags of garden salads recalled at ALDI, Jewel after outbreak of Cyclospora  WGN TV Chicago
4. FDA: Dozens sickened by salad sold at Hy-Vee, ALDI and other retailers  KGAN TV
5. Garden salad mix sold at Aldi, Hy-Vee, Jewel-Osco may be linked to Cyclospora outbreak in 6 states  USA TODAY
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Source: All MLB spring camps to temporarily close after positive coronavirus tests - ESPN

1. Source: All MLB spring camps to temporarily close after positive coronavirus tests  ESPN
2. Report: MLB to Close All Spring Training Facilities for Sanitizing  Sports Illustrated
3. Phillies have major coronavirus outbreak at spring training facility  New York Post
4. MLB to close all spring training sites in Florida and Arizona due to COVID-19 precautions, reports  WFLA
5. As long as there is Philly and fans, there is Phillies baseball  Philadelphia Phillies
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Navy upholds firing of carrier captain who warned of coronavirus - POLITICO

1. Navy upholds firing of carrier captain who warned of coronavirus  POLITICO
2. In major reversal, Navy opts to uphold firing of aircraft carrier captain who warned about coronavirus outbreak  CNN
3. Navy Inquiry Faults Two Top Officers Aboard Roosevelt for Handling of Virus  The New York Times
4. Navy won't reinstate captain fired for raising coronavirus concerns  NBC News
5. Navy won't reinstate fired captain | TheHill  The Hill
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June 19, 2020 at 09:25PM 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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Apple Again Closing Some Stores in Florida, Arizona, North Carolina and South Carolina Due to... - MacRumors

1. Apple Again Closing Some Stores in Florida, Arizona, North Carolina and South Carolina Due to...  MacRumors
2. Apple re-closing some stores in the U.S. amid Covid-19 case spikes  CNBC Television
3. Apple to close retail stores in 4 states amid coronavirus spikes  Yahoo Finance
4. Apple to close some stores in states where virus cases are rising  Financial Times
5. Apple will close select US retail stores again due to COVID-19 outbreaks  9to5Mac
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Cuomo brushes off criticism over nursing home deaths as 'shiny object' - Fox News

1. Cuomo brushes off criticism over nursing home deaths as 'shiny object'  Fox News
2. As the coronavirus surges in Oklahoma, rising fears of outbreaks in nursing homes  NBC News
3. Feds reject plan to use nursing home fines to pay for testing  Miami Herald
4. NJ Gov. Murphy snubs GOP House members asking about coronavirus nursing home policy  Fox News
5. Nursing homes represent more than 1 in 4 COVID-19 deaths in US  NBC News
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June 19, 2020 at 05:47PM Section 8200: Investigational New Drugs (INDs)

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

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June 19, 2020 at 04:33PM Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing

COVID-19 Guidance

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Beijing's new outbreak is a reminder to the world that coronavirus can return at anytime - CNN

1. Beijing's new outbreak is a reminder to the world that coronavirus can return at anytime  CNN
2. China finds heavy coronavirus traces in seafood, meat sections of Beijing food market  Reuters
3. Anxiety in Beijing as officials battle new coronavirus outbreak  The Guardian
4. Flights canceled, communities fenced off as coronavirus' return plunges Beijing into "soft lockdown"  CBS News
5. Beijing Market Tied to New COVID-19 Outbreak Has High Virus Concentrations  Newsweek
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June 19, 2020 at 11:46AM La tique à pattes rayées sous surveillance

Depuis 2015, le Cirad étudie la tique Hyalomma marginatum, régulièrement observée sur le littoral méditerranéen de France continentale. L’origine exacte de cette espèce, présente en Corse depuis plusieurs décennies, mais d’installation récente sur le continent, est encore inconnue. Contrairement à l’espèce Ixodes ricinus, cette tique n’est pas vectrice de la bactérie responsable de la maladie de Lyme. Mais elle peut transmettre le virus de la fièvre hémorragique de Crimée-Congo, virus non encore détecté en France.

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June 19, 2020 at 02:02AM 2020_02 Test Article FT 06

2020_05 Test Article some long description some long description.

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Flights canceled, communities fenced off as coronavirus' return plunges Beijing into "soft lockdown" - CBS News

1. Flights canceled, communities fenced off as coronavirus' return plunges Beijing into "soft lockdown"  CBS News
2. China finds heavy coronavirus traces in seafood, meat sections of Beijing food market  Reuters
3. Fears of second wave in China - as questions continue about origins of coronavirus - BBC News  BBC News
4. Beijing Raises Emergency Warning, Cancels 60% Of Incoming Flights  Forbes
5. Beijing’s new coronavirus outbreak carries an urgent message for the world  The Washington Post
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