September 30, 2021 at 11:17PM Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.

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September 30, 2021 at 03:12PM Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers

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

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September 30, 2021 at 03:01PM Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers

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

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September 30, 2021 at 02:49PM Roster of the Allergenic Products Advisory Committee

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

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September 30, 2021 at 02:42PM Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

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

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September 30, 2021 at 04:24AM Multilingual COVID-19 Vaccines Myths Social Media Toolkit

COVID-19 Vaccines Myths social media toolkit in English, Spanish, Chinese, Korean, Vietnamese and Tagalog.

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September 29, 2021 at 08:42PM CBER Advanced Technologies Program

In regulating the pharmaceutical manufacturing sector, FDA realizes the need for a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality biologics.

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September 29, 2021 at 06:36PM 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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September 29, 2021 at 05:05PM Benefit-Risk Assessment for New Drug and Biological Products

Biologics

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September 29, 2021 at 03:03PM Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices

Drug Safety

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September 29, 2021 at 02:24PM Cellular & Gene Therapy Guidances

This page contains a listing of cellular and gene therapy guidances.

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September 29, 2021 at 02:21PM Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations

This is the guidance for industry Interpreting Sameness Gene Therapy Products Orphan Drug Regulations

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September 29, 2021 at 02:17PM Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial

This is the draft guidance Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial

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September 28, 2021 at 10:17PM Jobs at the Center for Biologics Evaluation and Research (CBER)

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

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September 28, 2021 at 05:12PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Tissues and Advanced Therapies (OTAT).

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September 28, 2021 at 04:07PM Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products

Real World Data/Real World Evidence

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September 28, 2021 at 04:04PM Electronic Submission Template for Medical Device 510(k) Submissions

Guidance outlines standards for preparation of an e-submission template for 510(k)s that will enable submission of the 510(k) e-submission solely in electronic format.

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September 27, 2021 at 11:08PM Clinical Guidances

This page lists Clinical Guidance documents.

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Harvard Business School temporarily moves some MBA classes online to curb Covid outbreak - CNBC

1. Harvard Business School temporarily moves some MBA classes online to curb Covid outbreak  CNBC
2. BREAKING: Harvard Business School Moves MBA Classes Online As Covid Cases Surge  Yahoo Finance
3. Harvard Moves First-Year MBA Students Online as Covid Cases Surge  Bloomberg
4. Harvard Business School moves first-year MBA students online to deal with COVID-19 infections  BetaBoston
5. Harvard moves first-year MBA students online amid rise in 'breakthrough' COVID-19 cases | TheHill  The Hill
6. View Full Coverage on Google News

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September 27, 2021 at 08:27PM Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere

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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CDC removes guidance for phasing out masks in schools, say it's 'always being revised' - New York Post

1. CDC removes guidance for phasing out masks in schools, say it's 'always being revised'  New York Post
2. Masks in school help prevent Covid-19 outbreaks and spread, CDC studies find  CNN
3. As Florida punishes schools, study finds masks cut school COVID outbreaks 3.5X  Ars Technica
4. The Centers for Disease Control and Prevention published three reports that provide evidence that masking can help cut transmission of coronavirus within schools.  The Washington Post
5. WHO's Science in 5 on COVID-19 : Keeping schools safe  World Health Organization (WHO)
6. View Full Coverage on Google News

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September 24, 2021 at 08:42PM About the FDA and How You Can Get Involved

About the FDA and How You Can Get Involved

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September 24, 2021 at 08:05PM 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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September 24, 2021 at 03:52PM Remarks by Acting Commissioner Janet Woodcock at Scientific Adventures for Girls - 09/23/2021

Remarks byDr. Janet Woodcock
Acting Commissioner of Food and Drugs
Scientific Adventures for Girls
Sept. 23, 2021
San Francisco, CA

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September 24, 2021 at 03:49PM It’s 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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September 23, 2021 at 10:01PM Transfusion/Donation Fatalities

This page provides details on the Notification Process for Transfusion Related Fatalities and Donation Related Deaths.

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September 23, 2021 at 09:27PM Biologics Electronic Reading Room (eFOI)

The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.

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September 23, 2021 at 01:27AM FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of a single booster dose, to be administered at least six months after completion of the primary series with the Pfizer-BioNTech COVID-19 Vaccine in certain populations.

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September 22, 2021 at 10:09PM Patient Listening Session Summaries

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.

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September 22, 2021 at 10:01PM FDA Patient Listening Sessions

Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives.

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September 22, 2021 at 09:53PM Allergenic Products Advisory Committee October 28, 2021 Meeting Announcement - 10/28/2021 - 10/28/2021

This is the main page for the CBER Allergenic Products Advisory Committee October 28, 2021 Meeting Announcement.

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September 22, 2021 at 09:46PM 2021 Meeting Materials, Allergenic Products Advisory Committee

This is the main page for the CBER 2021 Meeting Materials, Allergenic Products Advisory Committee.

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September 22, 2021 at 09:45PM Meeting Materials, Allergenic Products Advisory Committee

This is the Past Meeting Materials, Allergenic Products Advisory Committee (APAC) landing page

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September 21, 2021 at 05:10PM Biosimilars Guidances

This page lists Biosimilars Guidance documents.

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September 20, 2021 at 10:29PM Patient Engagement Collaborative

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

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September 20, 2021 at 09:34PM CANDIN

Submission Tracking Number (STN) BL 103257/5066 has been assigned to your recent supplement to your biologics license application for Candida albicans Skin Test Antigen for Cellular Hypersensitivity, CANDIN®, dated April 5, 2016. Your submission is in the form of a “Supplement – Changes Being Effected” as described under 21 CFR 601.12(c)(5).

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September 20, 2021 at 08:12PM BIMO/Team Biologics/Internet Surveillance/Other

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

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September 17, 2021 at 09:05PM Coronavirus (COVID-19) Update: September 17, 2021

Coronavirus (COVID-19) Update: September 17, 2021

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Saints hit with COVID outbreak as Jameis Winston embraces new opportunity - Fox News

1. Saints hit with COVID outbreak as Jameis Winston embraces new opportunity  Fox News
2. OBJ isn't durable, Jameis can rebuild career in N.O., Jimmy G & Lance — Peter King | NFL | THE HERD  The Herd with Colin Cowherd
3. The NFL’s 6 burning questions entering Week 2  SB Nation
4. Film Study: Breakdown of every Jameis Winston dropback in Week 1  Canal Street Chronicles
5. Are Jameis Winston and the Saints the Best Bet to Unseat the Bucs in the NFC? | The Rich Eisen Show  The Rich Eisen Show
6. View Full Coverage on Google News

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Saints hit with COVID outbreak as Jameis Winston embraces new opportunity - Fox News

1. Saints hit with COVID outbreak as Jameis Winston embraces new opportunity  Fox News
2. OBJ isn't durable, Jameis can rebuild career in N.O., Jimmy G & Lance — Peter King | NFL | THE HERD  The Herd with Colin Cowherd
3. The NFL’s 6 burning questions entering Week 2  SB Nation
4. Film Study: Breakdown of every Jameis Winston dropback in Week 1  Canal Street Chronicles
5. Are Jameis Winston and the Saints the Best Bet to Unseat the Bucs in the NFC? | The Rich Eisen Show  The Rich Eisen Show
6. View Full Coverage on Google News

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September 16, 2021 at 07:09PM Berinert

Product approval information is indicated for treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.

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Jameis Winston relishing working closely with Sean Payton with assistants sidelined - NBC Sports

1. Jameis Winston relishing working closely with Sean Payton with assistants sidelined  NBC Sports
2. Sean Payton, Saints players did it for Louisiana | New Orleans Saints  New Orleans Saints
3. Winston praises Payton as Saints assistants deal with COVID  Fox News
4. AUDIO: Sean Payton discusses Saints COVID-19 outbreak  WDSU New Orleans
5. 'It's like Ted Lasso:' How the Saints are operating with multiple offensive coaches in COVID-19 isolation  NOLA.com
6. View Full Coverage on Google News

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September 16, 2021 at 04:49PM Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry

In October 2021, FDA incorporated Q2B Validation of Analytical Procedures: Methodology (May 1997)(Q2B) on methodology with the parent document Q2A Text on Validation of Analytical Procedures (March 1995)(Q2A) and retitled the combined document Q2(R1) Validation of Analytical Procedures: Text and Met

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States sound alarm over Covid-19 outbreaks among school kids - CNN

1. States sound alarm over Covid-19 outbreaks among school kids  CNN
2. How are schools deciding to close due to COVID-19 cases? It all depends.  The Philadelphia Inquirer
3. Analysis | Why the Delta Variant Is Giving More Children Covid  The Washington Post
4. Covid school quarantines are a new division we don't need right now  CNN
5. COVID cases start to decline among school-aged kids  11Alive
6. View Full Coverage on Google News

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September 13, 2021 at 04:51PM Compliance Actions (Biologics)

CBER carries out a wide range of compliance and surveillance activities during the "life cycle" of biological products

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China's latest Covid outbreak linked to primary school - BBC News

1. China's latest Covid outbreak linked to primary school  BBC News
2. COVID-19 cases in China's Fujian province more than double as Delta spreads  CNA
3. China imposes local lockdowns as COVID-19 cases surge  Yahoo News
4. Ensure safe and sound travel rebounds: China Daily editorial  The Straits Times
5. China rushes to contain 'school centered' Delta outbreak before major holiday season  CNN
6. View Full Coverage on Google News

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Russian President Putin Self-Isolates After Staffers Get COVID-19 - NPR

1. Russian President Putin Self-Isolates After Staffers Get COVID-19  NPR
2. "Let's see how Sputnik V works:" Putin self-isolating after COVID-19 outbreak in inner-circle  Global News
3. Putin in self-isolation due to COVID cases in inner circle  Yahoo News
4. Putin knocks US, Turkey during meeting with Syria's Assad | TheHill  The Hill
5. Vladimir Putin self-isolates after covid exposure but has not tested positive, Kremlin says  The Washington Post
6. View Full Coverage on Google News

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September 14, 2021 at 03:03PM FDA Voices on Medical Products

FDA Voices on Medical Products

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China's latest Covid outbreak linked to primary school - BBC News

1. China's latest Covid outbreak linked to primary school  BBC News
2. China's strict 21 day quarantine under question after new outbreak emerges  CNN
3. School-based COVID outbreak in China’s Fujian grows  Al Jazeera English
4. Ensure safe and sound travel rebounds: China Daily editorial  The Straits Times
5. China races to squash new Covid-19 cluster among schoolchildren  Yahoo Singapore News
6. View Full Coverage on Google News

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China's Fujian Province Reports Delta Outbreak - The New York Times

1. China's Fujian Province Reports Delta Outbreak  The New York Times
2. China's strict 21 day quarantine under question after new outbreak emerges  CNN
3. With Fresh Cases in Fujian, China Faces Another COVID-19 Outbreak  Sixth Tone
4. Chinese City Imposes Travel Curbs, Closes Public Venues In New Covid Outbreak  NDTV
5. Small businesses in China's Xian still struggling a year after controlling Covid-19 pandemic  South China Morning Post
6. View Full Coverage on Google News

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September 13, 2021 at 04:27PM S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS

ICH - Safety

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September 13, 2021 at 03:33PM Remarks by Dr. Woodcock to the RAPS (Regulatory Affairs Professionals Society) 2021 Convergence Conference - 09/12/2021

Remarks by Janet Woodcock, M.D.
Acting Commissioner of Food and Drugs
RAPS (Regulatory Affairs Professionals Society) 2021 Convergence Conference
Sept. 12, 2021

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September 13, 2021 at 03:14PM FDA Promotion Ceremony for the Public Health Service U.S. Commissioned Corps - 09/10/2021

Remarks by Janet Woodcock, M.D.
Acting Commissioner of Food and Drugs
FDA Promotion Ceremony for the Public Health Service U.S. Commissioned Corps
September 10, 2021

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September 13, 2021 at 02:09PM Meeting Materials, Blood Products Advisory Committee

This is the Meeting Materials, Blood Products Advisory Committee main landing page

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September 13, 2021 at 02:09PM 2021 Meeting Materials, Blood Products Advisory Committee

This is the main page for the CBER 2021 Meeting Materials, Blood Products Advisory Committee.

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September 13, 2021 at 02:08PM Blood Products Advisory Committee November 4, 2021 Meeting Announcement - 11/04/2021 - 11/04/2021

This is the CBER Blood Products Advisory Committee November 4, 2021 Meeting Announcement.

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New Zealand PM Jacinda Ardern: Sex Should Not Be Part of Hospital Visiting Hours - The Daily Beast

1. New Zealand PM Jacinda Ardern: Sex Should Not Be Part of Hospital Visiting Hours  The Daily Beast
2. Covid-19: Level 4 in Auckland extended, rest of NZ to stay in level 2  nzherald.co.nz
3. New Zealand keeps Auckland in strict lockdown to beat Delta  Yahoo News
4. Covid 19 coronavirus Delta outbreak: Wellington to remain at Delta level 2  New Zealand Herald
5. Don't expect any alert level changes for now  Otago Daily Times
6. View Full Coverage on Google News

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Why There Are Fears That Nipah Virus Could One Day Cause A Deadly Pandemic : Goats and Soda - NPR

1. Why There Are Fears That Nipah Virus Could One Day Cause A Deadly Pandemic : Goats and Soda  NPR
2. Nipah Virus: Karnataka On Guard, to Closely Monitor Arrivals from Kerala for Symptoms  News18
3. Nipah outbreak: Karnataka to keep close eye on arrivals from Kerala  Hindustan Times
4. Dead Boy's Contacts Test Negative, Kerala Nipah Source Not Identified Yet  NDTV
5. Kerala Govt Conducts Seroprevalence Study to Assess Coronavirus Spread  News18
6. View Full Coverage on Google News

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September 10, 2021 at 09:23PM Coronavirus (COVID-19) Update: September 10, 2021

Coronavirus (COVID-19) Update: September 10, 2021

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September 10, 2021 at 03:21PM FDA Will Follow The Science On COVID-19 Vaccines For Young Children

FDA leadership outlines steps the FDA will take to ensure the safety and efficacy of COVID-19 vaccines for young children

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September 10, 2021 at 02:04PM Resources for You (Biologics)

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

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September 09, 2021 at 06:58PM Health Fraud Scams

Learn how to spot health fraud and avoid it.

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September 08, 2021 at 09:24PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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September 08, 2021 at 05:53PM Section 8400: Marketing Applications

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

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September 08, 2021 at 03:10PM ICH Q12: Implementation Considerations for FDA-Regulated Products

ICH Q12: Implementation Considerations for FDA-Regulated Products

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Deadly Nipah virus outbreak reported in India; the mortality rate is higher than COVID-19 - PennLive

1. Deadly Nipah virus outbreak reported in India; the mortality rate is higher than COVID-19  PennLive
2. India fighting to contain Nipah, a virus deadlier than COVID-19  New York Post
3. What is the Nipah virus and why is it more deadly than COVID-19? A virus expert explains.  Yahoo News
4. Nipah virus: What are the most common symptoms? Is it deadly?  Deseret News
5. Indian state battered by COVID now on alert for Nipah virus  KSHB
6. View Full Coverage on Google News

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Nipah virus: Ramping up efforts to stop potential outbreak - WJW FOX 8 News Cleveland

1. Nipah virus: Ramping up efforts to stop potential outbreak  WJW FOX 8 News Cleveland
2. Authorities race to contain deadly Nipah virus outbreak in India  CBS News
3. Kerala Nipah Scare: Samples Of 8 Direct Contacts Of Nipah Victim Turns Negative, More Samples Tested  India Today
4. Kerala Officials Take Swab Samples Of Goat After Boy's Death Due To Nipah Virus  NDTV
5. What Is the Nipah Virus, What Is Its Death Rate? Outbreak Kills Boy, Hundreds Isolating  Newsweek
6. View Full Coverage on Google News

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Mystery fever in India identified as 2 separate pathogens as death toll tops 100 - CBS News

1. Mystery fever in India identified as 2 separate pathogens as death toll tops 100  CBS News
2. Dengue outbreak in Firozabad: How Gambusia fish is n..Uttar Pradeshs best bet to control vector-borne menace  Firstpost
3. Firozabad Viral Fever: Mysterious Scrub Typhus Fever Grips Uttar Pradesh | India Today Ground Report  India Today
4. Experts from PGI, KGMU to tackle fever cases in west Uttar Pradesh districts  Times of India
5. Uttar Pradesh CM seeks improved surveillance in districts battling dengue outbreak  The Hindu
6. View Full Coverage on Google News

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Authorities race to contain deadly Nipah virus outbreak in India - CBS News

1. Authorities race to contain deadly Nipah virus outbreak in India  CBS News
2. Kerala Nipah Scare: Samples Of 8 Direct Contacts Of Nipah Victim Turns Negative, More Samples Tested  India Today
3. Indian state battered by COVID now on alert for Nipah virus  ABC News
4. Samples from Kerala to be sent to Bhopal lab with Nipah source unknown  The New Indian Express
5. Kerala boy dies of Nipah virus  The Tribune India
6. View Full Coverage on Google News

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Authorities race to contain deadly Nipah virus outbreak in India - CBS News

1. Authorities race to contain deadly Nipah virus outbreak in India  CBS News
2. "It's Worrying": Expert As Kerala Battles High Covid Cases, Nipas Virus  NDTV
3. Kerala boy dies of Nipah virus  The Tribune India
4. 11 persons show Nipah symptoms; 30 healthcare workers isolated  The Hindu
5. Explained | Nipah, a highly pathogenic paramyxovirus  The Hindu
6. View Full Coverage on Google News

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Delta variant: Dr. Fauci reveals how to get full COVID-19 protection - Deseret News

1. Delta variant: Dr. Fauci reveals how to get full COVID-19 protection  Deseret News
2. Already vaccinated against Covid-19? Experts say you're protected, even without a booster shot  CNN
3. This Is the COVID Vaccine Stock You Want to Own  The Motley Fool
4. Fauci says Mu variant of Covid not an immediate threat to US but officials 'keeping a very close eye on it'  The Independent
5. Virus Outbreak: News and Analysis From Sept. 4  Bloomberg
6. View Full Coverage on Google News

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Kentucky governor calls special session to deal with COVID - WLWT Cincinnati

1. Kentucky governor calls special session to deal with COVID  WLWT Cincinnati
2. Gov. Beshear calls special session for legislature amid COVID-19 surge  WDRB
3. Kentucky Schools Struggle With Coronavirus Outbreaks  The New York Times
4. Governor Beshear calls Kentucky General Assembly into special session  WKYT
5. LEX 18 In-Depth: A look at Kentucky's ventilator capacity  LEX18 Lexington KY News
6. View Full Coverage on Google News

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COVID vaccine boosters: When is it time for that extra shot? Here's what we know - CNET

1. COVID vaccine boosters: When is it time for that extra shot? Here's what we know  CNET
2. Already vaccinated against Covid-19? Experts say you're protected, even without a booster shot  CNN
3. Virus Outbreak: News and Analysis From Sept. 4  Bloomberg
4. Biden's high-stakes booster tension with Moderna  Yahoo News
5. This Is the COVID Vaccine Stock You Want to Own  The Motley Fool
6. View Full Coverage on Google News

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September 02, 2021 at 11:09PM Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement - 09/17/2021 - 09/17/2021

This is the CBER Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement.

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September 02, 2021 at 10:22PM Novel and Emerging Therapies for Food Allergy

Alexander Zhovmer's research project "Novel and Emerging Therapies for Food Allergy".

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September 02, 2021 at 09:35PM Allergenics Research

List of Immunobiochemistry and Biologics Science & Research for Consumers - Allergenics Research

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September 02, 2021 at 09:28PM MCM-Related Counterterrorism Legislation

Since September 11, 2001, federal legislation has been enacted to strengthen the nation’s preparedness for responding to public health emergencies involving chemical, biological, radiological, nuclear (CBRN) as well as emerging infectious disease threats.

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September 02, 2021 at 08:36PM FDA Voices

Insights from FDA leadership and experts into the agency's work on policy, consumer safety & enforcement, medical products, food, & tobacco.

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September 02, 2021 at 05:56PM About the FDA and How Can You Get Involved

About the FDA and How Can You Get Involved

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September 02, 2021 at 03:45PM FDA’s National Center for Toxicological Research Celebrates Half a Century of Cutting-Edge Research

NCTR is celebrating 50 years of scientific achievements including the groundbreaking research we have done—and continue to do—in support of the FDA’s mission.

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September 01, 2021 at 10:54PM FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster

FDA announced a virtual VRBPAC meeting to discuss the Pfizer-BioNTech supplemental application for a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA).

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