May 28, 2021 at 08:51PM Model Informed Drug Development Approaches for Immunogenicity Assessments - 06/09/2021 - 06/09/2021

The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), in collaboration with the Center for Drug Evaluation and Research (CDER), are announcing the following public workshop entitled “Model Informed Drug Development Approaches for Immunogenicity Assessments.”

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7 million Australians ordered into new COVID-19 lockdown | TheHill - The Hill

1. 7 million Australians ordered into new COVID-19 lockdown | TheHill  The Hill
2. Melbourne lockdown: Fears over outbreak sparks restrictions  BBC News
3. Outbreak Prompts New Lockdown in Australia's Victoria State  The New York Times
4. Covid-19: WA slams border shut to Victoria following coronavirus outbreak  Herald Sun
5. Bad luck or bad management: why has Victoria had so many Covid outbreaks?  The Guardian
6. View Full Coverage on Google News

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U.S. Faces Outbreak of Anti-Semitic Threats and Violence - The New York Times

1. U.S. Faces Outbreak of Anti-Semitic Threats and Violence  The New York Times
2. Ilhan Omar decries attacks on Jews, defends 'legitimate criticism' of Israel  Business Insider
3. Four House Dems Label ‘Squad’ Statements on Israel ‘Antisemitic at Their Core’  National Review
4. How Jews can support Palestinian rights and condemn antisemitism  NBCNews.com
5. Stephens: Anti-Zionism isn’t anti-Semitism? Someone didn’t get the memo.  Austin American-Statesman
6. View Full Coverage on Google News

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Australia's Victoria state to enter COVID-19 lockdown after ... - Thomson Reuters Foundation

1. Australia's Victoria state to enter COVID-19 lockdown after ...  Thomson Reuters Foundation
2. Australian state has biggest one-day rise in COVID-19 cases in 7 months  Reuters
3. Hundreds of close contacts identified as Victoria's COVID outbreak grows | ABC News  ABC News (Australia)
4. Blockbuster in doubt, AFL investigating exposure site visit  Herald Sun
5. Victoria Covid-19 cases surge as lockdown expected  Yahoo News Australia
6. View Full Coverage on Google News

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Biden tells intelligence agencies to step up probe of COVID-19's origins, including theory of Wuhan lab leak - USA TODAY

1. Biden tells intelligence agencies to step up probe of COVID-19's origins, including theory of Wuhan lab leak  USA TODAY
2. Biden State Department quietly ended team's work probing COVID origin  Fox News
3. Biden tasks intelligence community to report on Covid origins in 90 days  CNN
4. Biden orders closer review of Covid origins as U.S. intel weighs Wuhan lab leak theory  CNBC
5. Biden: Intel community torn between 'two likely scenarios' on COVID-19 outbreak source  Fox News
6. View Full Coverage on Google News

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May 26, 2021 at 08:43PM Remarks by Acting Commissioner Woodcock to the Association for Accessible Medicines 2021Access! Conference - 05/26/2021

Opening Remarks for Association for Accessible Medicine 2021 Access! 2021 conference, Dr. Janet Woodcock, Acting Commissioner of Food and Drugs
May 26, Washington, DC.

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May 26, 2021 at 07:13PM Health Fraud Scams

Learn how to spot health fraud and avoid it.

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Biden orders closer review of Covid origins as U.S. intel weighs Wuhan lab leak theory - CNBC

1. Biden orders closer review of Covid origins as U.S. intel weighs Wuhan lab leak theory  CNBC
2. Biden: Intel community torn between 'two likely scenarios' on COVID-19 outbreak source  Fox News
3. Live updates: Biden asks intelligence community to redouble efforts to determine origin of the coronavirus  The Washington Post
4. Biden asks US intel officials to investigate COVID-19 origin  KXAN.com
5. William Shakespeare, first man to get vaccinated, dies at 81; antibodies remain 10 months after infection, study says: Live COVID-19 updates  USA TODAY
6. View Full Coverage on Google News

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May 26, 2021 at 03:49PM Remarks by Dr. Woodcock to the FDA Science Forum and introduction of Dr. Fauci - 05/26/2021

Remarks by Janet Woodcock, MD, Commissioner of Food and Drugs, FDA Science Forum, May 26, 2021, White Oak, MD

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Australia's Victoria state says next 24 hours critical as COVID cluster grows - Reuters

1. Australia's Victoria state says next 24 hours critical as COVID cluster grows  Reuters
2. COVID curbs reimposed in Melbourne after five cases discovered  Al Jazeera English
3. Victoria records six new Covid cases as state mulls lockdown  Yahoo News Australia
4. Melbourne Covid-19 outbreak spikes as lockdown fears grow  NEWS.com.au
5. Melbourne COVID-19 restrictions return as outbreak in northern suburbs grows to nine | ABC News  ABC News (Australia)
6. View Full Coverage on Google News

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May 26, 2021 at 03:00AM 2021_05 Test Article FT 04

2021_05 Test Article FT 04 Test Article some long description some long description.

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May 26, 2021 at 02:52AM 2021_05 Test Article FT 03

2021_05 Test Article some long description some long description.

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May 25, 2021 at 10:13PM Coronavirus (COVID-19) Update: May 25, 2021

Coronavirus (COVID-19) Update: May 25, 2021

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May 25, 2021 at 07:56PM Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates - 05/06/2021 - 05/06/2021

FDA is hosting a patient workshop on May 6, 2021. This workshop will bring together patients, caregivers, advocates, and other important stakeholders to discuss ways for patients and their advocates to work with FDA to help advance regenerative medicine for rare and genetic diseases.

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May 25, 2021 at 04:27PM ABBOTT PRISM HIV O Plus

Product approval information for the detection of antibodies to HIV-1 (anti-HIV-1) Groups M and O and/or antibodies to HIV-2 (anti-HIV-2) in human serum and plasma specimens.

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May 25, 2021 at 04:04PM ABBOTT PRISM HBcore

Product approval information is indicated for :
•Qualitative detection of total antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma
•Screening test for blood and plasma to prevent transmission of hepatitis B virus (HBV) to recipients of blood and blood components

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May 25, 2021 at 04:00PM Vaccine and Related Biological Product Guidances

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

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May 25, 2021 at 04:00PM Emergency Use Authorization for Vaccines to Prevent COVID-19

This is the Guidance for Industry for the Emergency Use Authorization for Vaccines to Prevent COVID-19. , COVID-19, Coronavirus Disease 2019, Vaccines , CBER, Biologics

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May 25, 2021 at 02:46PM FY 2019 Report from the Director

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

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May 25, 2021 at 02:05PM ABBOTT PRISM HCV

Product approval information is indicated for for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human serum and plasma specimens.

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Masks, social restrictions return to Australia's Melbourne after fresh outbreak - Reuters

1. Masks, social restrictions return to Australia's Melbourne after fresh outbreak  Reuters
2. Victoria records four new COVID infections as outbreak grows to nine | ABC News  ABC News (Australia)
3. COVID curbs reimposed in Melbourne after five cases discovered  Al Jazeera English
4. From 6pm Tonight, New Coronavirus Restrictions Are in Place for Greater Melbourne  Broadsheet
5. Melbourne Covid cluster grows to nine  Yahoo News Australia
6. View Full Coverage on Google News

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US has 'no means' to confirm if Wuhan lab workers got sick prior to COVID outbreak, Psaki says - New York Post

1. US has 'no means' to confirm if Wuhan lab workers got sick prior to COVID outbreak, Psaki says  New York Post
2. White House insists COVID-19 origins requires 'transparent' international investigation  Fox News
3. White House pushes for independent investigation on COVID-19 origins | TheHill  The Hill
4. As Lab-Leak Evidence Mounts, Psaki Says White House Is ‘Hopeful’ WHO Will Launch Second COVID Probe  National Review
5. Psaki: White House demands investigation into Ryanair flight diversion  POLITICO
6. View Full Coverage on Google News

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May 24, 2021 at 08:38PM Withdrawn - Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research; Draft Guidance for Industry

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

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May 24, 2021 at 08:04PM Therapeutic Cloning and Genome Modification

The rapid advances over the past few decades in biotechnologies involving somatic cells and gene therapy offer a great potential in regenerative medicine and for the treatment of genetic defects.

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May 24, 2021 at 05:01PM CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

CDER Scientific Reviews Supporting EUA for Therapeutic Products

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May 24, 2021 at 03:19PM FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act

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


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May 24, 2021 at 02:21PM Bispecific Antibody Development Programs Guidance for Industry

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the
availability of a draft guidance for industry entitled "Bispecific Antibody Development
Programs." This draft guidance provides recommendations to assist industry and other parties
involved in the bispecific antibody drug ..

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Intelligence on Sick Staff at Wuhan Lab Fuels Debate On Covid-19 Origin - The Wall Street Journal

1. Intelligence on Sick Staff at Wuhan Lab Fuels Debate On Covid-19 Origin  The Wall Street Journal
2. Fauci 'not convinced' COVID-19 developed naturally  Fox News
3. Wuhan Lab Staff Sought Hospital Care Before COVID-19 Outbreak Disclosed: WSJ  U.S. News & World Report
4. New information on Wuhan researchers' illness furthers debate on pandemic origins  CNN
5. Three Wuhan lab researchers were hospitalized in November 2019: report  New York Post
6. View Full Coverage on Google News

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Mount Everest COVID outbreak: Climbing guide says at least 100 virus cases - Fox News

Mount Everest COVID outbreak: Climbing guide says at least 100 virus cases  Fox NewsView Full Coverage on Google News

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Taiwan blames China for slowing down its access to Covid-19 vaccines. The reality is more complicated - CNN

1. Taiwan blames China for slowing down its access to Covid-19 vaccines. The reality is more complicated  CNN
2. Friday COVID-19 Indiana updates  WTHR
3. Taiwan accuses China of spreading fake news about Covid outbreak  The Guardian
4. Taiwan adds more domestic COVID cases, but sees trend stable  Yahoo News
5. Why Taiwan's COVID-19 Defenses Finally Faltered | Time - TIME  TIME
6. View Full Coverage on Google News

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Taiwan blames China for slowing down its access to Covid-19 vaccines. The reality is more complicated - CNN

1. Taiwan blames China for slowing down its access to Covid-19 vaccines. The reality is more complicated  CNN
2. Friday COVID-19 Indiana updates  WTHR
3. Taiwan accuses China of spreading fake news about Covid outbreak  The Guardian
4. Why Taiwan's COVID-19 Defenses Finally Faltered | Time - TIME  TIME
5. Coronavirus cases surge in Taiwan, the former COVID-19 success story  Deseret News
6. View Full Coverage on Google News

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May 21 coronavirus news - CNN

1. May 21 coronavirus news  CNN
2. Why Mitt Romney wants to speed up vaccine distribution to the world  Deseret News
3. COVID-19 Deaths in Latin America Surpass 1 Million as Outbreak Worsens  U.S. News & World Report
4. Latin America poised to benefit as U.S. raises exports of Covid-19 shots, sources say  CNBC
5. Exclusive: Latin America poised to benefit as U.S. raises exports of COVID-19 shots - sources  Yahoo News
6. View Full Coverage on Google News

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May 21, 2021 at 07:57PM HCT/P Inspection Information

This is the main page for the CBER HCT/P Inspection Information.

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May 21, 2021 at 04:28PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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May 21, 2021 at 04:20PM 2021 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the CBER 2021 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).

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May 21, 2021 at 04:19PM Vaccines and Related Biological Products Advisory Committee June 10, 2021 Meeting Announcement - 06/10/2021 - 06/10/2021

This is the CBER Vaccines and Related Biological Products Advisory Committee June 10, 2021 Meeting Announcement.

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May 21, 2021 at 01:14PM Procleix Ultrio Elite Assay

•Intended to screen for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA and to detect human immunodeficiency virus type 2 (HIV-2) RNA, in plasma and serum specimens from individual human donors, including donors of whole blood, blood compo

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May 21, 2021 at 12:21PM Procleix Ultrio Assay

Product approval information is intended 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.
• Used in conjunction with licensed tests for detecting antibodies to HIV-1, HCV, and hepatitis B core antigen (anti-HBc), and with licensed tests for hepatitis B surface antigen (HBsAg).

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May 20, 2021 at 08:00PM ICH Q12: Implementation Considerations for FDA-Regulated Products

ICH Q12: Implementation Considerations for FDA-Regulated Products

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Taiwan Faces a Surge in New Covid-19 Infections - The New York Times

1. Taiwan Faces a Surge in New Covid-19 Infections  The New York Times
2. Trust, science and access play major role in global pandemic health outcomes.  KARE 11
3. The Latest: Taiwan's worst outbreak of the pandemic grows  Yahoo News
4. Why Taiwan, long a COVID success story, is seeing a record surge in cases  CBS News
5. Taiwan Adds 286 Local Covid Cases, Avoids Full Lockdown  Bloomberg
6. View Full Coverage on Google News

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May 20, 2021 at 03:23PM Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products

Biostatistics

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Covid-19: What went wrong in Singapore and Taiwan? - BBC News

1. Covid-19: What went wrong in Singapore and Taiwan?  BBC News
2. The Latest: Taiwan's worst outbreak of the pandemic grows  Associated Press
3. Asia Suffers Outbreaks Where Covid-19 Had Seemed Beaten  The Wall Street Journal
4. COVID-19 pandemic continues to hinder jury trials  WVTM 13 News
5. The narrative around Taiwan's COVID success story obscures the very real challenges Taiwanese people endure  Business Insider
6. View Full Coverage on Google News

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Covid-19: What went wrong in Singapore and Taiwan? - BBC News

1. Covid-19: What went wrong in Singapore and Taiwan?  BBC News
2. Asia Suffers Outbreaks Where Covid-19 Had Seemed Beaten  The Wall Street Journal
3. The narrative around Taiwan's COVID success story obscures the very real challenges Taiwanese people endure  Business Insider
4. Taiwan raises COVID alert islandwide, but gets vaccine boost  Yahoo News
5. Restrictions reimposed as virus resurges in much of Asia  The Associated Press
6. View Full Coverage on Google News

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May 19, 2021 at 11:45PM FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available

FDA authorized undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.

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May 19, 2021 at 10:03PM Administrative Guidances

This page lists Administrative Guidance documents.

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May 19, 2021 at 09:46PM 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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May 19, 2021 at 02:53PM Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)

Information Sheet Guidance
for Sponsors, Clinical Investigators, and IRBs

Frequently Asked Questions
Statement of Investigator
(Form FDA 1572) (Revision 1)


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May 18, 2021 at 09:46PM KEDRAB

• Product approval information is indicated for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal and concurrently with a full course of rabies vaccine.

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Millions in Texas are under flash flood warnings due to torrential rain - CNN

1. Millions in Texas are under flash flood warnings due to torrential rain  CNN
2. Severe weather outbreak brings flash floods, tornadoes in South  ABC News
3. After historic rain and flood event, more showers and storms possible  WBRZ
4. Pct. 4 Constables preparing for threat of severe weather  KPRC 2 Click2Houston
5. Flood watch remains through this evening; heavy rain possible  FOX 8 Live WVUE
6. View Full Coverage on Google News

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May 18, 2021 at 06:11PM Remarks by FDA Acting Commissioner Janet Woodcock to the FDLI Annual Conference - 05/18/2021

Remarks by Janet Woodcock, M.D., Acting Commissioner Food and Drugs to the FDLI Annual Conference, May 18, 2021, Washington, DC

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May 18, 2021 at 02:29PM 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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Virus Outbreak: News and Analysis From May 17 - Bloomberg

Virus Outbreak: News and Analysis From May 17  Bloomberg

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May 17, 2021 at 08:29PM FDA Voices on Policy

FDA Voices on Policy

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May 17, 2021 at 07:47PM Investigational New Drug Applications (INDs) for CBER-Regulated Products

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

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May 17, 2021 at 07:38PM Pandemic Influenza Information

Pandemic influenza (flu) is a significant global public health threat. Preparedness has been recognized as a critical local, national and worldwide priority

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May 17, 2021 at 06:47PM Advancing FDA’s Mission by Targeting Key Areas for Regulatory Science Investment and Innovation

The FARS Report communicates the importance and impact of the FDA’s regulatory science research activities and identifies cross-cutting areas that need sustained or new investment to fulfill the FDA’s mission.

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May 17, 2021 at 05:33PM Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers

Manufacturing, Supply Chain, and Drug and Biological Product ...Q&A
Covid-19

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May 17, 2021 at 05:18PM Blood Products Advisory Committee July 18-19, 2018 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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May 17, 2021 at 03:06PM COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention

COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention

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Taiwan was a Covid success story. Now it's fighting its biggest outbreak - CNN

1. Taiwan was a Covid success story. Now it's fighting its biggest outbreak  CNN
2. Lockdowns and panic-buying in Taiwan as Covid cases rise  The Guardian
3. The Latest: Taiwan Has Another Jump, Capital Closing Schools  U.S. News & World Report
4. Taiwan scrambles for vaccines as domestic COVID-19 cases rise  Yahoo News
5. How did Covid slip through Taiwan’s ‘gold standard’ defences?  The Guardian
6. View Full Coverage on Google News

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Taiwan, Singapore Tighten Travel Restrictions as Covid Cases Climb - Bloomberg

1. Taiwan, Singapore Tighten Travel Restrictions as Covid Cases Climb  Bloomberg
2. Success story Taiwan faces its worst outbreak in pandemic  Yahoo News
3. Indiana COVID-19 updates - May 14, 2021  WTHR
4. Taiwan Tightens Curbs After Surge in Domestic COVID-19 Cases  U.S. News & World Report
5. Taiwan raises coronavirus alert level as residents stockpile toilet paper and food  The Washington Post
6. View Full Coverage on Google News

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Starbucks, Walt Disney World relax mask rules after change in CDC guidance - NBC News

1. Starbucks, Walt Disney World relax mask rules after change in CDC guidance  NBC News
2. Starbucks, Publix and other places loosen mask restrictions for fully vaccinated  CNN
3. Heading out to shop at Publix? You won't need to wear a mask if you're fully vaccinated  WPLG Local 10
4. Virus Outbreak: News and Analysis From May 15  Bloomberg
5. Publix drops mask rules for fully vaccinated customers and employees  WFLA News Channel 8
6. View Full Coverage on Google News

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Vaccinate vulnerable global poor before children in rich countries, WHO says - The Guardian

1. Vaccinate vulnerable global poor before children in rich countries, WHO says  The Guardian
2. Supply of everyday items are short amid ongoing COVID-19 pandemic  WBAL-TV 11 Baltimore
3. Covid: Delay child vaccinations and share jabs with Covax, says WHO  BBC News
4. How did an outbreak become a pandemic? Too easily.  The Washington Post
5. Pandemic to be 'far more deadly' this year, WHO warns  Yahoo News
6. View Full Coverage on Google News

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Vaccinate vulnerable global poor before children in rich countries, WHO says - The Guardian

1. Vaccinate vulnerable global poor before children in rich countries, WHO says  The Guardian
2. Supply of everyday items are short amid ongoing COVID-19 pandemic  WBAL-TV 11 Baltimore
3. Covid: Delay child vaccinations and share jabs with Covax, says WHO  BBC News
4. How did an outbreak become a pandemic? Too easily.  The Washington Post
5. Pandemic to be 'far more deadly' this year, WHO warns  Yahoo News
6. View Full Coverage on Google News

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Covid: Delay child vaccinations and share jabs with Covax, says WHO - BBC News

1. Covid: Delay child vaccinations and share jabs with Covax, says WHO  BBC News
2. Coronavirus pandemic has had major impact on opioid crisis  wgaltv
3. Supply of everyday items are short amid ongoing COVID-19 pandemic  WBAL-TV 11 Baltimore
4. How did an outbreak become a pandemic? Too easily.  The Washington Post
5. Vaccinate vulnerable global poor before children in rich countries, WHO says  The Guardian
6. View Full Coverage on Google News

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Virus Outbreak: News and Analysis From May 15 - Bloomberg

Virus Outbreak: News and Analysis From May 15  Bloomberg

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The Yankees’ covid-19 outbreak shows vaccines work, health experts say - The Washington Post

1. The Yankees’ covid-19 outbreak shows vaccines work, health experts say  The Washington Post
2. How surprising are the vaccinated Yankees’ COVID-19 cases? Experts explain the implications  Yahoo Sports
3. COVID-19 outbreak hits New York Yankees  Good Morning America
4. Explainer: Why Did Yankees Test Positive After Vaccination?  U.S. News & World Report
5. Yankees shortstop Gleyber Torres tests positive for COVID-19  Montreal Gazette
6. View Full Coverage on Google News

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May 14, 2021 at 09:57PM Towards Longer-Acting Factor VIII Products with Better Purity

A description of Andrey Sarafanov's research program and related publications.

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Covid: Delay child vaccinations and share jabs with Covax, says WHO - BBC News

1. Covid: Delay child vaccinations and share jabs with Covax, says WHO  BBC News
2. Coronavirus pandemic has had major impact on opioid crisis  wgaltv
3. Vaccinate vulnerable global poor before children in rich countries, WHO says  The Guardian
4. How did an outbreak become a pandemic? Too easily.  The Washington Post
5. Idaho nurse looks back at the last 6 months of the COVID-19 pandemic  KTVB
6. View Full Coverage on Google News

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May 14, 2021 at 08:36PM Cell-specific And Gene-specific Targeting of Gene Therapy Vectors

A description of Jakob Reiser's research program and related publications.

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Eight from Yankees test positive for Covid in post-vaccine breakthrough cases - NBC News

1. Eight from Yankees test positive for Covid in post-vaccine breakthrough cases  NBC News
2. New York Yankees say 8 vaccinated members tested positive for Covid-19. Here's how that could happen  CNN International
3. COVID-19 outbreak hits New York Yankees  Good Morning America
4. How surprising are the vaccinated Yankees’ COVID-19 cases? Experts explain the implications  Yahoo Sports
5. How Can You Still Test Positive For COVID After Being Fully Vaccinated?  CBS New York
6. View Full Coverage on Google News

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May 12, 2021 at 11:50PM Meetings with the Office of Orphan Products Development

Guidance for industry, researchers, patient groups, and FDA staff on meetings with the Office of Orphan Products Development

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New York Yankees say 8 fully vaccinated team members have tested positive for COVID-19 - CBS News

1. New York Yankees say 8 fully vaccinated team members have tested positive for COVID-19  CBS News
2. COVID-19 outbreak hits New York Yankees  Good Morning America
3. New York Yankees say 8 vaccinated members tested positive for Covid-19. Here's how that could happen  CNN International
4. Brian Cashman Stresses ‘The Vaccine is Working’ Amid Yankees’ Outbreak  Sports Illustrated
5. Albanese: More positive Yanks show there's ways to go in battle with COVID-19  Newsday
6. View Full Coverage on Google News

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May 14, 2021 at 02:03AM 2021_05 Test Article FT 02

2021_05 Test Article FT 02 Test Article some long description some long description.

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May 13, 2021 at 12:19AM Early Development Considerations for Innovative Combination Products

Guidance for Industry and FDA Staff -Early Development Considerations for Innovative Combination Products

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May 13, 2021 at 12:14AM Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product

Guidance for Industry and FDA Staff - Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product

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May 13, 2021 at 12:10AM Application User Fees for Combination Products

Guidance for Industry and FDA Staff - Application User Fees for Combination Products

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May 12, 2021 at 11:53PM Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions

Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions

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May 13, 2021 at 09:48PM Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA

Draft guidance for industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA

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May 13, 2021 at 12:06AM How to Write a Request for Designation (RFD)

Guidance for Industry - How to Write a Request for Designation (RFD)

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May 13, 2021 at 12:05AM Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

Guidance for Industry and FDA Staff: Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

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May 13, 2021 at 12:02AM Classification of Products as Drugs and Devices and Additional Product Classification Issues

Guidance for Industry and FDA Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues

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May 12, 2021 at 11:50PM Meetings with the Office of Orphan Products Development

Guidance for industry, researchers, patient groups, and FDA staff on meetings with the Office of Orphan Products Development

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May 12, 2021 at 11:46PM Humanitarian Use Device (HUD) Designations

Guidance for Industry and FDA Staff - Humanitarian Use Device (HUD) Designations

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May 13, 2021 at 08:07PM Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry


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May 13, 2021 at 12:22AM Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Guidance for Industry and FDA Staff - Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

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May 13, 2021 at 03:08PM Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection

Page for Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection, and Withdrawal of Guidance titled “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components

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World's Most Vaccinated Nation Is Spooked by COVID Spike - Yahoo News

1. World's Most Vaccinated Nation Is Spooked by COVID Spike  Yahoo News
2. Alarming COVID-19 resurgence in world's most vaccinated nation leads to questions about Chinese vaccine | TheHill  The Hill
3. Seychelles, World's Most Vaccinated Country, Says Covid Vaccines Work  Bloomberg
4. COVID outbreak in world’s most vaccinated country ‘mostly among people who haven’t had jab’  Yahoo News
5. COVID cases double in the world’s most-vaccinated nation  The Detroit News
6. View Full Coverage on Google News

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Taiwan's Stock Crash Deepens as Traders Unwind Leveraged Bets - Bloomberg

1. Taiwan's Stock Crash Deepens as Traders Unwind Leveraged Bets  Bloomberg
2. Taiwanese cities tighten restrictions after COVID-19 cases rise  Yahoo News
3. Covid-19 Concerns and Chip Selloff Roil Taiwanese Market  The Wall Street Journal
4. Taiwan sees a small outbreak, and its stock market plunges.  The New York Times
5. 16 new cases cause worry in Taiwan, Tsai says don't panic  The Associated Press
6. View Full Coverage on Google News

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These Researchers Paved The Way For The Covid Vaccine - NBC News

1. These Researchers Paved The Way For The Covid Vaccine  NBC News
2. Many U.S. States with Bad Recent Outbreaks Show Case and Hospitalization Drops  The New York Times
3. Hillsborough student with cystic fibrosis plans return to the classroom after COVID-19 vaccination  WFLA News Channel 8
4. What India's 2nd COVID-19 wave may mean for countries in Africa  ABC News
5. 'This is something we take seriously': UPMC doctor discusses COVID-19 vaccines for children  WTAE-TV Pittsburgh
6. View Full Coverage on Google News

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Will Vaccines Work On Coronavirus Variant From India? : Goats and Soda - NPR

1. Will Vaccines Work On Coronavirus Variant From India? : Goats and Soda  NPR
2. Scientists race to study Indian coronavirus variant as cases explode  Fox News
3. The B.1.617 variant is now in 44 countries. We don't yet know what that means for the global pandemic  CNN
4. Covid-19 live updates: CDC endorses use of coronavirus vaccine for 12- to 15-year-olds  The Washington Post
5. Virus Strain Behind Deadly India Outbreak Detected in 44 Nations  Bloomberg
6. View Full Coverage on Google News

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May 12, 2021 at 07:46PM Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

Guidance for Industry - Drug Safety

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May 12, 2021 at 03:12PM 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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May 12, 2021 at 03:56PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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May 12, 2021 at 03:21PM Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection, and Withdrawal of Guidance titled “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components”

This is the guidance Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection, and Withdrawal of Guidance titled “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components

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May 12, 2021 at 01:56PM Blood Establishment Registration and Product Listing

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

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May 11, 2021 at 09:16PM Withdrawn Guidances (Biologics)

This page displays withdrawn CBER guidance documents

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May 10, 2021 at 07:30PM Temporada de huracanes: Prepárese

Es importante preparar las provisiones de emergencia y mantener a salvo los alimentos, el agua y los medicamentos antes, durante y después de cualquier cambio climático severo.

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May 11, 2021 at 08:11PM 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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May 11, 2021 at 01:37PM E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials

International Conference on Harmonisation - Efficacy

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May 11, 2021 at 02:59PM Q3D(R2) – Guideline for Elemental Impurities

International Council for Harmonisation; Draft Guidance for Industry

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May 11, 2021 at 02:18PM S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals

S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals ; International Council for Harmonisation; Draft Guidance for Industry; Availability

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May 11, 2021 at 02:12PM Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex

International Council for Harmonisation-Quality

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May 11, 2021 at 02:07PM Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry

International Council for Harmonisation-Quality

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May 11, 2021 at 01:55PM S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals

International Council for Harmonisation - Safety Revision 3

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China is to partition Mount Everest’s summit to reduce coronavirus risk. - The New York Times

1. China is to partition Mount Everest’s summit to reduce coronavirus risk.  The New York Times
2. China To Set Up 'Line Of Separation' On Mount Everest, Citing Nepal COVID-19 Outbreak  NPR
3. Nepal urges Everest climbers to return used oxygen canisters amid Covid crisis  The Guardian
4. Everest: China to set up 'separation line' at summit  BBC News
5. China to draw 'separation line' on peak of Mount Everest  The Associated Press
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Nepal urges Everest climbers to return used oxygen canisters amid Covid crisis - The Guardian

1. Nepal urges Everest climbers to return used oxygen canisters amid Covid crisis  The Guardian
2. China To Set Up 'Line Of Separation' On Mount Everest, Citing Nepal COVID-19 Outbreak  NPR
3. Mother-Daughter Duo Tackles Mount Everest  CBS New York
4. China to create 'line of separation' at Everest summit over Covid fears  CNN
5. Everest: China to set up 'separation line' at summit  BBC News
6. View Full Coverage on Google News

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May 11, 2021 at 12:02AM Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions

Answers to frequently asked questions about the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19.

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May 10, 2021 at 11:05PM Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic

The FDA expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents down to 12 years of age.

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May 10, 2021 at 10:39PM Pfizer-BioNTech COVID-19 Vaccine

Information about the Pfizer-BioNTech COVID-19 vaccine

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China is to partition Mount Everest’s summit to reduce coronavirus risk. - The New York Times

1. China is to partition Mount Everest’s summit to reduce coronavirus risk.  The New York Times
2. China to create 'line of separation' at Everest summit over Covid fears  CNN
3. Mother-Daughter Duo Tackles Mount Everest  CBS New York
4. Everest: China to set up 'separation line' at summit  BBC News
5. China To Set Up 'Line Of Separation' On Mount Everest, Citing Nepal COVID-19 Outbreak  NPR
6. View Full Coverage on Google News

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May 07, 2021 at 08:16PM YESCARTA (axicabtagene ciloleucel)

YESCARTA is a treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

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