China reports 55 new COVID-19 cases as Delta variant spreads from Nanjing - Yahoo News

1. China reports 55 new COVID-19 cases as Delta variant spreads from Nanjing  Yahoo News
2. In China, A Coronavirus Delta Variant Outbreak Spreads To 15 Cities : Coronavirus Updates  NPR
3. China sees its worst Covid outbreak since Wuhan  The Tribune India
4. Nanjing COVID outbreak is China’s most severe since Wuhan  New York Daily News
5. China on 'high alert' as delta variant of Covid-19 spreads to 5 provinces  NBC News
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In China, A Coronavirus Delta Variant Outbreak Spreads To 15 Cities : Coronavirus Updates - NPR

1. In China, A Coronavirus Delta Variant Outbreak Spreads To 15 Cities : Coronavirus Updates  NPR
2. Concerns raised over WA's hospital system and its ability to cope with a COVID-19 outbreak | 7.30  ABC News (Australia)
3. China on 'high alert' as delta variant of Covid-19 spreads to 5 provinces  NBC News
4. Nanjing: New virus outbreak worst since Wuhan, say Chinese state media  Yahoo News
5. Nanjing Delta Outbreak Tests China's Tough Approach to Covid  The New York Times
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In China, A Coronavirus Delta Variant Outbreak Spreads To 15 Cities : Coronavirus Updates - NPR

1. In China, A Coronavirus Delta Variant Outbreak Spreads To 15 Cities : Coronavirus Updates  NPR
2. Nanjing: New virus outbreak worst since Wuhan, say Chinese state media  BBC News
3. China on 'high alert' as delta variant of Covid-19 spreads to 5 provinces  NBC News
4. Recent COVID outbreak in China's Nanjing linked to flight from Russia - official  Yahoo News
5. Delta Variant Tests China’s Covid-19 Strategy  The Wall Street Journal
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July 30, 2021 at 10:46PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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Australia Sends Troops To Enforce Sydney Coronavirus Lockdown : Coronavirus Updates - NPR

1. Australia Sends Troops To Enforce Sydney Coronavirus Lockdown : Coronavirus Updates  NPR
2. Covid in Sydney: Military deployed to help enforce lockdown  BBC News
3. Sydney readies for the army as lockdown fails to squash Australia Delta outbreak  CNN
4. Fears army on the streets of Sydney sends the wrong message - Breakfast  ABC News
5. Don’t Let the Pandemic Tear Australia Apart  The New York Times
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In China, A Coronavirus Delta Variant Outbreak Spreads To 15 Cities : Coronavirus Updates - NPR

1. In China, A Coronavirus Delta Variant Outbreak Spreads To 15 Cities : Coronavirus Updates  NPR
2. Nanjing: New virus outbreak worst after Wuhan, say Chinese state media  BBC News
3. Concerns raised over WA's hospital system and its ability to cope with a COVID-19 outbreak | 7.30  ABC News (Australia)
4. Covid-19 and Vaccine News: Live Updates  The New York Times
5. Nanjing: New virus outbreak worst after Wuhan, says China state media  Yahoo News
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July 30, 2021 at 06:28PM 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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Nanjing: New China virus outbreak worst after Wuhan, says state media - BBC News

1. Nanjing: New China virus outbreak worst after Wuhan, says state media  BBC News
2. Beijing reports first Covid case in 179 days as alarm grows over Nanjing Delta cluster  CNN
3. China's delta outbreak tests limits of zero-tolerance covid approach  The Washington Post
4. Delta variant spreads to China in one of its largest outbreaks| Oneindia News  Oneindia News
5. City of Nanjing isolated as China fights worst Covid outbreak in months  The Guardian
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July 29, 2021 at 07:05PM FDA 101: Product Recalls

Here's a breakdown of FDA's role in product recalls, from the moment the agency is notified to successful completion of the recall.

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July 29, 2021 at 06:02PM Identifying Recalled Products

Think you may have a recalled product? Watch this video to learn who to contact and how to identify a recalled product by the numbers and dates on the packaging.

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July 29, 2021 at 04:08PM 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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China's delta outbreak tests limits of zero-tolerance covid approach - The Washington Post

1. China's delta outbreak tests limits of zero-tolerance covid approach  The Washington Post
2. Beijing reports first Covid case in 179 days as alarm grows over Nanjing Delta cluster  CNN
3. City of Nanjing isolated as China fights worst Covid outbreak in months  The Guardian
4. Delta Variant's Spread Now Hits China In One Of Its Largest Outbreaks  NDTV
5. China steps up port, driver checks after new virus cases  Associated Press
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Whistleblowers say they were told to downplay Covid outbreak among migrant kids at shelter - NBC News

1. Whistleblowers say they were told to downplay Covid outbreak among migrant kids at shelter  NBC News
2. Migrant child coronavirus outbreak: Whistleblowers say they were told to downplay infections at Fort Bliss  Fox News
3. US used contractors with no child care experience to run migrant facilities: whistleblowers | TheHill  The Hill
4. Migrant children in U.S. tent camp faced depression and filthy conditions, whistleblowers say  CBS News
5. Whistleblowers allege poor conditions at Fort Bliss facility for migrant children  CNN
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July 28, 2021 at 02:59PM Biosimilar and Interchangeable Biologics: More Treatment Choices

The FDA has approved biosimilar medications to treat conditions such as cancer, diabetes, Crohn’s disease, colitis, rheumatoid arthritis, psoriasis, and more.

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Norway Unseats the U.S. as Best Place to Be in Covid - Bloomberg

1. Norway Unseats the U.S. as Best Place to Be in Covid  Bloomberg
2. Norway again postpones end to Covid lockdown  Times of India
3. Covid-19 Virus Outbreak: News and Analysis From July 28  Bloomberg
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July 26, 2021 at 03:09PM Seraclone Blood Grouping Reagent Anti-Fya(Monoclonal)

Product approval information is indicated for the determination of the blood group antigens on red blood cells using the tube test.

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July 26, 2021 at 05:12PM Seraclone Blood Grouping Reagents and Anti-Human Globulin Reagents (STN# 125213, 125215, 125217, 125219 - 125233, 125242)

Product approval information is indicated for the determination of the blood group antigens on red blood cells and detecting in vivo and /or in vitro coating of red blood cells using the tube test.

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July 26, 2021 at 03:43PM Biotestcell and Erytypecell

Product approval information is indicated for use in manual tube testing and Reagent Red Blood Cells For Use in Automated Systems are for use on the TANGO® optimo automated blood grouping and antibody test system.

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July 27, 2021 at 09:40PM Vaccines Research

List of Vaccines Research.

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July 27, 2021 at 09:35PM Evaluation of the Quality of Viral Vaccines Based on Molecular Consistency

A description of Konstantin Chumakov's research program and related publications.

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July 27, 2021 at 08:47PM 2021 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

This is the main page for the CBER 2021 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee.

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July 27, 2021 at 08:46PM Cellular, Tissue, and Gene Therapies Advisory Committee September 2-3, 2021 Meeting Announcement - 09/02/2021 - 09/03/2021

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee September 2-3, 2021 Meeting Announcement.

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July 27, 2021 at 07:09PM Development of Quantitative Assays to Evaluate the Safety of Cell Substrates and Vaccines

A description of Keith Peden's research program and related publications.

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July 26, 2021 at 08:41PM IDELVION

Product approval information is indicated for children and adults with hemophilia B (congenital Factor IX deficiency) for 1) On-demand control and prevention of bleeding episodes; 2) Perioperative management of bleeding; 3) Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

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July 27, 2021 at 04:52PM Influenza neuraminidase antigenicity and efficacy in vaccines

Robert Daniels' research project "Influenza neuraminidase antigenicity and efficacy in vaccines".

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Cases of COVID-19 linked to Provincetown outbreak found in Minnesota - Bring Me The News

1. Cases of COVID-19 linked to Provincetown outbreak found in Minnesota  Bring Me The News
2. Federal law doesn't prohibit Covid-19 vaccine requirements, Justice Department says  CNN
3. Is California’s vaccine pace picking up amid COVID surge? Here’s what the numbers show  Sacramento Bee
4. Want to work in San Francisco city government? You'll need to be vaccinated  San Francisco Chronicle
5. Massage therapist says she is not vaccinated. Customers seek refund but she refuses.  NJ.com
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Department of Veterans Affairs will require health workers to be vaccinated - CNN

1. Department of Veterans Affairs will require health workers to be vaccinated  CNN
2. COVID-19 In Pennsylvania: State Health Department Reports 3-Day Total Of 1,696 New Cases, 7 Additional Deaths  CBS Pittsburgh
3. COVID-19 hospitalizations rise by 50 over weekend in Pa.: update  PennLive
4. More COVID-19 shots are being given in Pa. and N.J. as delta variant spurs outbreaks in U.S.  The Philadelphia Inquirer
5. Centre County Adds 3 COVID-19 Cases; Pennsylvania Reports 556 New Positives  State College News
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July 26, 2021 at 10:51PM Development of New Immunological Assays and Animal Models to Evaluate Vaccine Safety and Efficacy Against Emerging Diseases

A description of H. Golding's research program and related publications.

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July 26, 2021 at 09:23PM 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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July 26, 2021 at 04:14PM SHINGRIX

This is the main page for the CBER SHINGRIX.

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Children sent home from Iowa summer camp after staff COVID-19 outbreak - KCCI Des Moines

Children sent home from Iowa summer camp after staff COVID-19 outbreak  KCCI Des MoinesView Full Coverage on Google News

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Oregon communities struggle to control massive Bootleg fire - Los Angeles Times

1. Oregon communities struggle to control massive Bootleg fire  Los Angeles Times
2. ‘A Recipe for Catastrophic Fire’: How an Oregon Blaze Became the Nation’s Largest  The New York Times
3. Wildfires out west creating hazy skies in St. Louis  KTVI Fox 2 St. Louis
4. Hundreds are still under evacuation orders as the nation's largest wildfire chars more than 400,000 acres  CNN
5. Oregon firefighters face return of hazardous conditions, COVID-19 outbreak  Reuters
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New Zealand-Australia travel bubble bursts - CNN

1. New Zealand-Australia travel bubble bursts  CNN
2. Jacinda Ardern announces Australian travel bubble suspension as Covid outbreak worsens  Guardian News
3. New Zealand suspends quarantine-free travel with Australia as Covid bubble bursts  NBC News
4. New Zealand Suspends Quarantine-Free Travel From Australia  The New York Times
5. Asia Today: N Zealand suspends travel bubble with Australia  The Washington Post
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July 21, 2021 at 04:50PM FluMist Quadrivalent

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

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New Zealand-Australia travel bubble bursts - CNN

1. New Zealand-Australia travel bubble bursts  CNN
2. Jacinda Ardern announces Australian travel bubble suspension as Covid outbreak worsens  Guardian News
3. Australia-New Zealand travel bubble popped by delta outbreak  The Washington Post
4. New Zealand suspends quarantine-free travel with Australia as Covid bubble bursts  NBC News
5. New Zealand shuts Australia travel bubble as Sydney’s Covid outbreak worsens  The Guardian
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Former Texans star DeAndre Hopkins questions NFL future because he won't get vaccine - Chron

1. Former Texans star DeAndre Hopkins questions NFL future because he won't get vaccine  Chron
2. NFL says COVID outbreaks may force teams to forfeit games  CBS Evening News
3. Colts’ low vaccination rate could upend season based on new COVID rules  Horseshoe Heroes
4. NFL offers financial incentive for players to get vaccinated  CNBC Television
5. DeAndre Hopkins among players to react to NFL's vaccine memo to teams  ESPN
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July 23, 2021 at 01:54AM 2021_07 Test Article EDITED FT 01

2021_07 Test Article some long description some long description.

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July 22, 2021 at 11:17PM Janssen COVID-19 Vaccine Frequently Asked Questions

Answers to frequently asked questions about FDA's Emergency Use Authorization of the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

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Why Vaccinated People Are Getting ‘Breakthrough’ Infections - The New York Times

1. Why Vaccinated People Are Getting ‘Breakthrough’ Infections  The New York Times
2. Purdue Touts High Student COVID-19 Vaccination Rates  WLFITV
3. Woman loses unvaccinated family members to COVID-19, warns others to get immunized  KFYR-TV
4. More than 90% of adult Beijing residents fully vaccinated against COVID-19  Yahoo News
5. The latest on the coronavirus outbreak for July 22  CBC.ca
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NFL says coronavirus outbreaks among unvaccinated players may lead to forfeits this season - CNN

1. NFL says coronavirus outbreaks among unvaccinated players may lead to forfeits this season  CNN
2. NFL teams will be forced to forfeit if unvaccinated players cause COVID-19 outbreak  New York Post
3. NFL: Teams will forfeit games that can't be rescheduled due to COVID-19 outbreaks among unvaccinated  CBS Sports
4. How NFL's memo on COVID-19 outbreaks, forfeits impacts Bengals  Bengals Wire
5. COVID outbreak during season could lead to Vikings forfeit, no paychecks  Bring Me The News
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July 22, 2021 at 03:48PM FDA Seeks Patient Insight: Call for Applications for the Patient Engagement Collaborative

The FDA is announcing the call for applications for the next cohort of the Patient Engagement Collaborative.

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July 22, 2021 at 03:28PM Field Alert Report Submission: Questions and Answers Guidance for Industry

Pharmaceutical Quality/Manufacturing Standards (CGMP).
and Pharmaceutical Quality/CMC.

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July 20, 2021 at 08:53PM FDA Patient Engagement Opportunities

A description of some of the opportunities for patients, caregivers and advocates to engage with the FDA.

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July 20, 2021 at 08:35PM 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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July 21, 2021 at 04:04PM Human Gene Therapy for Neurodegenerative Diseases

This is the draft guidance for industry, Human Gene Therapy for Neurodegenerative Diseases.

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Aroldis Chapman's Yankees nightmare appears over - New York Post

1. Aroldis Chapman's Yankees nightmare appears over  New York Post
2. Phillies vs. Yankees Game Highlights (7/20/21) | MLB Highlights  MLB
3. MLB COVID outbreak: Phillies share Yankees’ pain  NJ.com
4. Yankees fan destroyed by security after running on field in latest Bronx fiasco  New York Post
5. Today on Pinstripe Alley - 7/21/21  Pinstripe Alley
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Psaki not calling Texas Dems' trip to DC a 'super-spreader' as more officials test positive - Fox News

1. Psaki not calling Texas Dems' trip to DC a 'super-spreader' as more officials test positive  Fox News
2. Texas Democrats Face Covid Outbreak and a Stalled Voting Rights Push  The New York Times
3. COVID-19 Derails Texas Democrats Lobbying in Washington  NBC 5 Dallas-Fort Worth
4. Editorial: Republicans claim Texas' voting bill just rolls back pandemic-era changes. Nice try.  Houston Chronicle
5. Graham says adding amnesty to infrastructure bill could be ‘dumbest idea’ in history of the Senate, WH  Fox News
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July 19, 2021 at 11:16PM Remarks by Dr. Woodcock to the Regulatory Education for Industry Conference - 07/19/2021

Remarks by Janet Woodcock, MD
Acting Commissioner of Food and Drugs
2021 FDA Regulatory Education for Industry Conference
July 19, 2021
White Oak, MD

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July 19, 2021 at 03:36PM Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines

A major paradigm shift is necessary from the systemic exclusion to the inclusion of pregnant and breastfeeding women in clinical studies.

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Virus Outbreak: News and Analysis From July 18 - Bloomberg

1. Virus Outbreak: News and Analysis From July 18  Bloomberg
2. France: Thousands protest against vaccination, COVID passes  Yahoo News
3. Protests in France continue to grow after Macron enacts new COVID-19 measures | TheHill  The Hill
4. Europe Gets Tough on Vaccinations as Threats Replace Incentives  Bloomberg
5. Protesters want 'freedom' amid Macron vaccine push  Yahoo News
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Protests in France continue to grow after Macron enacts new COVID-19 measures | TheHill - The Hill

1. Protests in France continue to grow after Macron enacts new COVID-19 measures | TheHill  The Hill
2. France: Thousands protest against vaccination, COVID passes  Yahoo News
3. Virus Outbreak: News and Analysis From July 17, 2021  Bloomberg
4. France greenlights India-made AstraZeneca vaccine for international visitors | TheHill  The Hill
5. France should consider mandatory COVID shots for public in case epidemic worsens, says health body  Yahoo News
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Yankees Select Three Players, Place Luke Voit On Injured List - MLB Trade Rumors

1. Yankees Select Three Players, Place Luke Voit On Injured List  MLB Trade Rumors
2. Sources - Aaron Judge among six New York Yankees to test positive for COVID-19  ESPN
3. Best: Thursday's bombshell a reminder we're not all the way back  Newsday
4. Yankees COVID-19 outbreak: Aaron Judge among six Yankees to test positive; Red Sox game Friday will be played  CBS Sports
5. Boston Red Sox, New York Yankees to play Friday after COVID-19 postponement  ESPN
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July 16, 2021 at 01:15PM 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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Yankees’ roster options if COVID outbreak includes Aaron Judge, Gio Urshela, Kyle Higashioka - NJ.com

1. Yankees’ roster options if COVID outbreak includes Aaron Judge, Gio Urshela, Kyle Higashioka  NJ.com
2. Sources - Aaron Judge among six New York Yankees to test positive for COVID-19  ESPN
3. Best: Thursday's bombshell a reminder we're not all the way back  Newsday
4. Game postponed after 6 New York Yankees have tested positive for Covid-19, team says  CNN
5. Should the Yankees be trade deadline buyers or sellers? Who could actually help? Who could they trade?  The Athletic
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Boston Red Sox vs. New York Yankees game postponed after multiple Yankees test positive for COVID-19 - ESPN

1. Boston Red Sox vs. New York Yankees game postponed after multiple Yankees test positive for COVID-19  ESPN
2. Yankees-Red Sox postponed due to Yankees COVID scare  New York Post
3. Lennon: Yankees can't afford any more faceplants  Newsday
4. Red Sox/Yankees Game Postponed Due To Yankees' COVID-19 Outbreak  MLB Trade Rumors
5. Yankees News, 7/15: Bombers call up young outfield stud dominating Triple-A to bigs  Empire Sports Media
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July 15, 2021 at 06:30PM Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015

Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and FDA Staff

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China's Tokyo Olympics delegation will be nation's biggest yet for an international sporting event - South China Morning Post

1. China's Tokyo Olympics delegation will be nation's biggest yet for an international sporting event  South China Morning Post
2. With fans barred from the Olympics, the question looms: Why isn't Japan more vaxxed?  Yahoo Sports
3. Athletes to put on own Olympic medals in Tokyo to prevent virus spread  ESPN
4. Coronavirus Outbreaks at the Tokyo Olympics  U.S. News & World Report
5. Michael Andrew, Olympic gold medal favorite, defends decision to remain unvaccinated for Tokyo  Yahoo Sports
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Indonesia overtakes India as Asia's new Covid-19 epicenter - CNN

1. Indonesia overtakes India as Asia's new Covid-19 epicenter  CNN
2. Grappling with 'worst-case scenario', Indonesia faces more COVID-19 pain  Yahoo News
3. Indonesia is bracing for worsening Covid outbreak as cases spike  CNBC
4. COVID-19 outbreaks: How Indonesia became Asia’s new epicenter  Deseret News
5. Indonesia reports 54,000 virus cases, becomes Asian hotspot  Yahoo News
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Catt Sadler sick with COVID-19 after being fully vaccinated: 'Delta is relentless' - Fox News

1. Catt Sadler sick with COVID-19 after being fully vaccinated: 'Delta is relentless'  Fox News
2. Viewer question: How many vaccinated vs. unvaccinated Idaho residents are dying each day?  KTVB
3. Alabama military base orders troops to show vaccination proof amid increased COVID-19 cases | TheHill  The Hill
4. A closer look at Georgia's COVID-19 numbers  11Alive
5. COVID-19 outbreaks at daycare centers, summer camps; COVID hospitalizations up for adults  FOX 8 Live WVUE
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July 14, 2021 at 07:03PM Improving Safety and Potency Testing of Allergen Extracts

A description of Jay Slater's research program and related publications.

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July 14, 2021 at 04:47PM PREA Non-Compliance Letters

PREA Non-Compliance Letters

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July 13, 2021 at 10:51PM Coronavirus (COVID-19) Update: July 13, 2021

Coronavirus (COVID-19) Update: July 13, 2021

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July 13, 2021 at 10:26PM Fast Track Designation Request Performance

The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling submission" for a marketing application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.

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July 13, 2021 at 03:44AM 2021_07 Test Article FT 01

2021_07 Test Article some long description some long description.

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July 12, 2021 at 10:43PM COVID-19 Vaccine Safety Surveillance

This page describes the monitoring the safety of authorized COVID-19 vaccines through both passive and active safety surveillance systems.

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July 12, 2021 at 10:43PM Initial Results of Near Real-Time Safety Monitoring of COVID-19 Vaccines in Persons Aged 65 Years and Older

This page describes the Initial Results of Near Real-Time Safety Monitoring of COVID-19 Vaccines in Persons Aged 65 Years and Older

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July 12, 2021 at 05:07PM FDA to Discuss COVID-19’s Impact on Medical Product Operations at SBIA REdI Annual Conference

FDA will co-host the Small Business Industry and Assistance (SBIA) Regulatory Education for Industry (REdI) Annual Conference, which will provide an overview of our regulatory operations during COVID-19.

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July 12, 2021 at 02:10PM Blood & Blood Products

CBER regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components. FDA has strengthened the safeguards that protect patients from unsuitable blood and blood products and has increased its oversight of the blood industry.

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July 12, 2021 at 02:08PM Regulation of the Blood Supply

Regulation of the Blood Supply

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Australia's COVID-19 Delta outbreak worsens despite Sydney lockdown - Yahoo News

1. Australia's COVID-19 Delta outbreak worsens despite Sydney lockdown  Yahoo News
2. First local COVID-19 death reported this year in Australia | TheHill  The Hill
3. Australia's Covid outbreak grows despite Sydney lockdown  CNBC
4. Australia records first COVID-19 death of 2021  Yahoo News
5. Sydney Lockdown 'Highly Unlikely' to be Lifted as Cases Rise  Bloomberg
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Covid-19 Pandemic: Live Updates and News for July 11, 2021 - Bloomberg

1. Covid-19 Pandemic: Live Updates and News for July 11, 2021  Bloomberg
2. Australia’s Delta Outbreak Shows Vaccines Protect Against Hospitalization  The Wall Street Journal
3. Federal government considers further assistance for states and territories during Covid outbreaks  The Guardian
4. Sydney Lockdown 'Highly Unlikely' to be Lifted as Cases Rise  Bloomberg
5. Locked-down Sydney warned worse may be ahead, COVID-19 cases at 2021 high  Yahoo News
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Global Covid: woman dies in Sydney’s Delta outbreak, 745 new cases in Germany - The Guardian

1. Global Covid: woman dies in Sydney’s Delta outbreak, 745 new cases in Germany  The Guardian
2. S.Korea reports third consecutive record high new COVID-19 cases -KDCA  Yahoo News
3. South Korea Covid Cases Still Surging Ahead of Curbs in Capital  Bloomberg
4. Seoul heads for lockdown as infections spiral in South Korea  The Guardian
5. The Latest: S. Korea hits third-straight high in virus cases  Yahoo News
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S.Korea reports third consecutive record high new COVID-19 cases -KDCA - Yahoo News

1. S.Korea reports third consecutive record high new COVID-19 cases -KDCA  Yahoo News
2. Lockdowns toughen in Seoul and Sydney as Delta variant Covid-19 outbreaks grow  CNN
3. South Korea reverses loosening of mask mandate, ramps up curbs as cases soar  The Washington Post
4. Officials Tighten Restrictions In Seoul Amid Another Wave Of COVID-19 Infections  NPR
5. Seoul heads for lockdown as infections spiral in South Korea  The Guardian
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July 09, 2021 at 10:41PM 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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July 09, 2021 at 10:10PM Coronavirus (COVID-19) Update: July 9, 2021

Coronavirus (COVID-19) Update: July 9, 2021

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July 09, 2021 at 09:18PM Joint CDC and FDA Statement on Vaccine Boosters

Joint CDC and FDA Statement on Vaccine Boosters

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July 09, 2021 at 08:21PM Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-based Products (HCT/Ps)

This is the CBER HCT/Ps Q&As- End of Compliance and Enforcement Policy main page with information for health care providers, clinics and regulated industry need to know about the end of FDA's compliance and enforcement policy, which ended on May 31, 2021 if they offer certain HCT/Ps.

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July 09, 2021 at 06:16PM Cellular & Gene Therapy Products

CBER provides oversight of clinical studies, proactive scientific and regulatory advice to medical researchers and manufacturers of cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy.

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July 09, 2021 at 06:28PM Biosimilars Guidances

This page lists Biosimilars Guidance documents.

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July 09, 2021 at 03:52PM Influenza Virus Vaccine Composition and Lot Release

Influenza Virus Vaccine Composition and Lot Release

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S.Korea raises Seoul COVID-19 curbs to top level, new cases set 2nd straight national record - Yahoo News

1. S.Korea raises Seoul COVID-19 curbs to top level, new cases set 2nd straight national record  Yahoo News
2. Lockdowns toughen in Seoul and Sydney as Delta variant Covid-19 outbreaks grow  CNN
3. South Korea raises Covid restrictions to highest level in Seoul amid ‘maximum crisis’  The Guardian
4. South Korea reverses loosening of mask mandate, ramps up curbs as cases soar  The Washington Post
5. COVID cases and South Korea: Why are cases up? Will it go into lockdown?  Deseret News
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COVID-19 outbreak in Tyson Fury camp jeopardizing fight vs. Deontay Wilder, sources say - ESPN

1. COVID-19 outbreak in Tyson Fury camp jeopardizing fight vs. Deontay Wilder, sources say  ESPN
2. When will Tyson Fury and Deontay Wilder fight? Bout could be postponed after COVID-19 breakout in Fury camp  Sporting News
3. Report: Tyson Fury vs. Deontay Wilder Fight in Jeopardy Due to COVID-19 Outbreak  Bleacher Report
4. Tyson Fury vs. Deontay Wilder trilogy fight reportedly jeopardized due to COVID-19 outbreak in Fury's camp  DAZN News US
5. Deontay Wilder Puts His One-Punch Knockout Power on Display Against Dominic Breazeale  Premier Boxing Champions
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Australia's Largest City Sydney Locks Down For A Third Week - NPR

1. Australia's Largest City Sydney Locks Down For A Third Week  NPR
2. Sydney sees highest Covid cases in months despite lockdown  BBC News
3. Sydney's two-week lockdown extended for third week as Delta variant spreads  New York Post
4. Lockdown in Sydney doesn’t mean staying locked in. It’s Covid-safer to be outside  The Guardian
5. Covid: Sydney lockdown extended as Delta outbreak spreads  Yahoo News
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Utah’s COVID-19 outbreak now 6th worst in the U.S. - Deseret News

1. Utah’s COVID-19 outbreak now 6th worst in the U.S.  Deseret News
2. Worldwide COVID death toll tops 4 million  New York Daily News
3. World Health Organization says governments should use ‘extreme caution’ in fully lifting COVID-19 restrictions  KTLA
4. WHO blasts abhorrent "vaccine nationalism" as global COVID death toll passes 4 million  CBS News
5. WHO urges extreme caution against completely lifting public health measures  CNBC
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July 07, 2021 at 10:42PM OCTAGAM

Product approval information is indicated for the treatment of chronicimmune purpura (ITP) in adults

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Australia's largest city Sydney locks down for third week - Associated Press

1. Australia's largest city Sydney locks down for third week  Associated Press
2. Sydney locked down for another week as Delta COVID-19 variant spreads  Yahoo News
3. Delta mutations mean young people less protected against Covid, experts warn  The Guardian
4. Sydney's two-week lockdown extended for third week as Delta variant spreads  New York Post
5. Covid: Sydney lockdown extended as Delta outbreak spreads  Yahoo News
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