As Shanghai expands COVID lockdown, life on hold in city of 26 million - Reuters

1. As Shanghai expands COVID lockdown, life on hold in city of 26 million  Reuters
2. Covid lockdown extended in Shanghai as outbreaks put economy on the skids  The Guardian
3. China's zero-Covid policy tests small businesses in a make-or-break it year  CNBC
4. China reopens 1 city as Shanghai lockdown enters 2nd phase  ABC News
5. China Censors Shanghai Protest Videos as Lockdown Anger Grows  Bloomberg
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April 01, 2022 at 02:03AM 2022_03 Test Article EDITED FT 02

2022_03 Test Article some long description some long description.

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March 31, 2022 at 10:31PM Webinars and Outreach

CBER sponsored webinars for public and industry.

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Deadly tornadoes hit South as severe storm threat shifts east - The Washington Post

1. Deadly tornadoes hit South as severe storm threat shifts east  The Washington Post
2. Severe weather spawns nearly 30 tornadoes in 7 states  WHAS11
3. Severe Weather Outbreak Live Updates: Two Killed by Florida Tornado | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
4. Severe storms pummel South killing at least 2 in Florida  WKMG News 6 & ClickOrlando
5. 2 killed as severe weather hits Florida Panhandle, with more strong storms possible Thursday along East Coast  CNN
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Powerful Storm Kills at Least 2 in Florida Panhandle - The New York Times

1. Powerful Storm Kills at Least 2 in Florida Panhandle  The New York Times
2. Severe Weather Outbreak Live Updates: Two Killed by Florida Tornado | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
3. 2 deaths reported after storms hit the Florida Panhandle  WFAA
4. 2 killed as severe weather hits Florida Panhandle, with more strong storms possible Thursday along East Coast  CNN
5. At least 2 people killed in Florida Panhandle after tornado touches down  First Coast News
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March 31, 2022 at 02:42PM Vaccine and Related Biological Product Guidances

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

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March 31, 2022 at 02:42PM 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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March 30, 2022 at 08:42PM RegenMedEd Webinar: The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases - 03/09/2022

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a public webinar on Wednesday, March 9, 2022, from 11:00 a.m. - 12:00 p.m. ET.

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March 30, 2022 at 04:46PM FDA’s Technology and Data Modernization in Action in 2022

As we mark the one-year anniversary of the agency’s Data Modernization Action Plan, and nearly three years since launching the agency’s Technology Modernization Action Plan, we are pleased to provide an update on our progress with the report: “Modernization in Action.”

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March 29, 2022 at 09:48PM 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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March 29, 2022 at 09:17PM Do I qualify for a COVID-19 vaccine booster and which one?

Do I qualify for a COVID-19 vaccine booster and which one?

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March 29, 2022 at 06:01PM Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

Information about the Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

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March 29, 2022 at 04:30PM Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

The FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.

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March 29, 2022 at 03:35PM Vaccines and Related Biological Products Advisory Committee April 6, 2022 Meeting Announcement - 04/06/2022

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee April 6, 2022 Meeting Announcement.

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March 28, 2022 at 11:04PM Devices Guidances

This page lists Medical Device Guidance documents.

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March 28, 2022 at 10:11PM Administrative Guidances

This page lists Administrative Guidance documents.

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China: Shanghai to lock down for testing as COVID surges - Al Jazeera English

1. China: Shanghai to lock down for testing as COVID surges  Al Jazeera English
2. Shanghai to lock down each half of city for mass Covid-19 testing  CNN
3. Shanghai Imposes Largest Citywide Lockdown in China Since Pandemic's Start  The Daily Beast
4. Much of Shanghai locked down as mass COVID-19 testing begins  The Associated Press - en Español
5. Shanghai imposes lockdown in effort to control omicron outbreak | TheHill  The Hill
6. View Full Coverage on Google News

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March 25, 2022 at 08:19PM Vaccines and Related Biological Products Advisory Committee March 3, 2022 Meeting Announcement - 03/03/2022

This is the CBER Vaccines and Related Biological Products Advisory Committee March 3, 2022 Meeting Announcement.

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Miami Beach streets quiet as curfew goes into effect following spring break violence - Fox News

1. Miami Beach streets quiet as curfew goes into effect following spring break violence  Fox News
2. Miami Beach declares state of emergency following outbreak of violence during spring break  CBS Mornings
3. Curfew Officially Underway For Miami Beach's Entertainment District  CBS Miami
4. Miami Beach banning alcohol sales after 6 p.m. this weekend amid violent spring break season  FOX 13 Tampa
5. Miami Beach has one goal: to keep people safe during Spring Break | Opinion  Miami Herald

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Miami Beach bans evening alcohol sales after spring break spirals into violence - Fox Business

1. Miami Beach bans evening alcohol sales after spring break spirals into violence  Fox Business
2. Miami Beach declares state of emergency following outbreak of violence during spring break  CBS Mornings
3. Miami Beach Commission Approves State Of Emergency, Curfew  CBS Miami
4. Miami Beach banning alcohol sales after 6 p.m. this weekend amid violent spring break season  FOX 13 Tampa
5. Miami Beach shootings bring emergency curfew to spring break  The Washington Post
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Photos: Widespread damage in Arabi, Lower Ninth Ward after tornado - WDSU New Orleans

1. Photos: Widespread damage in Arabi, Lower Ninth Ward after tornado  WDSU New Orleans
2. Cleanup Begins After Tornado Outbreak Across the South | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
3. 'My house is gone': Residents describe harrowing experience as tornadoes swept through New Orleans area, killing 1  CNN
4. National Weather Service continues surveys in tornado-damaged areas  WDSU New Orleans
5. Two schools in St. Bernard closed. Most others open Wednesday  NOLA.com
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March 24, 2022 at 01:43PM Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

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March 18, 2022 at 02:54PM CROFAB

CroFab is indicated for the management of adult and pediatric patients with North American crotalid envenomation.

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Photos: Widespread damage in Arabi, Lower Ninth Ward after tornado - WDSU New Orleans

1. Photos: Widespread damage in Arabi, Lower Ninth Ward after tornado  WDSU New Orleans
2. New Orleans, surrounding areas, ravaged by tornado as severe weather moves into Deep South, 1 dead  Fox News
3. Tornado Looks Electric As It Rips Up Exploding Power Lines  Inside Edition
4. Two schools in St. Bernard closed. Most others open Wednesday  NOLA.com
5. Cleanup Begins After Tornado Outbreak Across the South | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
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Crews comb through devastated neighborhoods in the New Orleans area after a tornado kills 1 and leaves thousands without power - CNN

1. Crews comb through devastated neighborhoods in the New Orleans area after a tornado kills 1 and leaves thousands without power  CNN
2. New Orleans, surrounding areas, ravaged by tornado as severe weather moves into Deep South, 1 dead  Fox News
3. Cleanup Begins After Tornado Outbreak Across the South | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
4. Two schools in St. Bernard closed. Most others open Wednesday  NOLA.com
5. Tornado Looks Electric As It Rips Up Exploding Power Lines  Inside Edition
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Devastation In Texas After String Of Storms - NBC News

1. Devastation In Texas After String Of Storms  NBC News
2. Storms tear into Texas, Oklahoma then move into Deep South  KSL.com
3. Tornadoes damaged an estimated 1,000 homes in Texas and now the storm is spawning more twisters in Mississippi and Louisiana  CNN
4. Storm warnings nix hundreds of flights at DFW Airport, Dallas Love Field  The Dallas Morning News
5. Tornado outbreak hits Texas, Oklahoma l GMA  ABC News
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Severe storms and tornado risk threaten the South today after powerful system tears through Texas - CNN

1. Severe storms and tornado risk threaten the South today after powerful system tears through Texas  CNN
2. Aerial footage of North Texas storm damage  WFAA
3. Raw video shows tornado damage in Jacksboro, Texas  KHOU 11
4. Storm warnings nix hundreds of flights at DFW Airport, Dallas Love Field  The Dallas Morning News
5. Tornado outbreak reported in Texas as much of South braces for severe weather  Yahoo News
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At least 4 injured after tornadoes pound Texas, Oklahoma; tens of thousands without power - USA TODAY

1. At least 4 injured after tornadoes pound Texas, Oklahoma; tens of thousands without power  USA TODAY
2. Raw video shows tornado damage in Jacksboro, Texas  KHOU 11
3. Tornado outbreak reported in Texas as much of South braces for severe weather  Yahoo News
4. NWS: Cold front brings risk of severe weather, including heavy rain to Houston area  Houston Chronicle
5. No injuries after severe storm causes 'catastrophic damage' to two schools in Texas  CNN

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Severe storms move through North Texas; some damage reported - The Dallas Morning News

1. Severe storms move through North Texas; some damage reported  The Dallas Morning News
2. Raw video shows tornado damage in Jacksboro, Texas  KHOU 11
3. Tornado outbreak reported in Texas as much of South braces for severe weather  Yahoo News
4. Thunderstorms, high winds pound North Texas; at least 4 hurt  Fort Worth Star-Telegram
5. No injuries after severe storm causes 'catastrophic damage' to two schools in Texas  CNN
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At least 4 injured after tornadoes pound Texas, Oklahoma; tens of thousands without power - USA TODAY

1. At least 4 injured after tornadoes pound Texas, Oklahoma; tens of thousands without power  USA TODAY
2. Raw video shows tornado damage in Jacksboro, Texas  KHOU 11
3. Tornado outbreak reported in Texas as much of South braces for severe weather  Yahoo News
4. Jacksboro animal shelter damaged, Humane Society WC to house pets  KFDX - Texomashomepage.com
5. Many damaged buildings but no reported injuries so far in Jacksboro  WFAA
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Severe storms move through North Texas; some damage reported - The Dallas Morning News

1. Severe storms move through North Texas; some damage reported  The Dallas Morning News
2. Raw video shows tornado damage in Jacksboro, Texas  KHOU 11
3. Tornado outbreak reported in Texas as much of South braces for severe weather  Yahoo News
4. NWS: Cold front brings risk of severe weather, including heavy rain to Houston area  Houston Chronicle
5. Many damaged buildings but no reported injuries so far in Jacksboro  WFAA

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Dangerous Texas thunderstorms kick of southern severe weather outbreak - The Washington Post

1. Dangerous Texas thunderstorms kick of southern severe weather outbreak  The Washington Post
2. Southern Plains brace for severe weather  CBS Evening News
3. Weather news: Strong tornadoes could affect major Southern cities  CNN
4. Weather: Significant severe weather risk Tuesday  WWLTV
5. How storms in Texas could bring storms to Orlando, Central Florida  FOX 35 Orlando
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March 21, 2022 at 02:02PM Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

On Wed., April 6, FDA will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations for future COVID-19 vaccine booster doses and the strain selection process to address current and emerging variants during the Fall season 2022.

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March 18, 2022 at 09:34PM 2022 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the CBER 2022 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).

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Dangerous days ahead with severe weather forecast through next week - NBC News

1. Dangerous days ahead with severe weather forecast through next week  NBC News
2. Powerful storms cause injuries, damage in Southeast as forecast calls for strong winds, hail and possibly tornadoes  CNN
3. First Alert to strong to severe storms possible next week  Action News 5
4. Dangerous storms target South today ahead of severe outbreak Monday  The Washington Post
5. Powerful storms Friday could bring damaging winds and hail to Southeast  msnNOW
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Powerful storms could bring damaging winds, hail and possibly tornadoes to the Southeast - CNN

1. Powerful storms could bring damaging winds, hail and possibly tornadoes to the Southeast  CNN
2. Dangerous days ahead with severe weather forecast through next week  msnNOW
3. Dangerous storms target South today ahead of severe outbreak Monday  The Washington Post
4. Severe weather season heats up as hail, wind and tornadoes threaten the South  CNN
5. Powerful storms could bring damaging winds, hail and possibly tornadoes for the Southeast – KION546  KION
6. View Full Coverage on Google News

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March 18, 2022 at 01:49PM CARVYKTI

For the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

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March 17, 2022 at 04:17PM APTIMA HIV-1 RNA Qualitative Assay

Product approval information is indicated for use as an aid in diagnosis of HIV-1 infection, including acute or primary infection.

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March 17, 2022 at 04:14PM Zoster Vaccine Recombinant, Adjuvanted

Zoster Vaccine Recombinant, Adjuvanted

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Oil Rebounds As Market Fears Russian Supply Shock - OilPrice.com

1. Oil Rebounds As Market Fears Russian Supply Shock  OilPrice.com
2. Oil prices rise on supply concerns  Fox Business
3. Did China’s COVID outbreak change gas prices?  Deseret News
4. Stock market news: Stocks decline as oil rises to over $100 a barrel  Markets Insider
5. U.S. oil pushes back above $100 a barrel  MarketWatch
6. View Full Coverage on Google News

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March 17, 2022 at 03:52PM Typhoid Vi Polysaccharide Vaccine

List of Typhoid Vi Polysaccharide Vaccine

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March 17, 2022 at 03:50PM Typhoid Vaccine Live Oral Ty21a

Typhoid Vaccine Live Oral Ty21a

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March 17, 2022 at 03:40PM Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

List of Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) products

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March 16, 2022 at 03:34PM Section 8500: Compliance

This is the SOPP Section 8500: Compliance main page.

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March 16, 2022 at 02:27PM Spikevax and Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine and Spikevax

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China’s Covid-19 Surge Shuts Down Plants in Manufacturing Hubs Shenzhen and Changchun - The Wall Street Journal

1. China’s Covid-19 Surge Shuts Down Plants in Manufacturing Hubs Shenzhen and Changchun  The Wall Street Journal
2. Covid-19 cases continue to rise in China's worst outbreak since Wuhan  CNN
3. China Covid spike: Shenzhen shuts production, Shanghai closes schools  CNBC
4. COVID Finally Spins Out of Control in China as New Variant Takes Hold  Yahoo News
5. COVID-19 cases more than double in China's growing outbreak  The Associated Press - en Español

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China's Covid outbreak will cause 'some disruption' to tech supply chains, says Marvell CEO - CNBC

1. China's Covid outbreak will cause 'some disruption' to tech supply chains, says Marvell CEO  CNBC
2. Apple supplier Foxconn halts operations in Shenzhen as China locks down tech hub  CNN
3. Shenzhen COVID Spike expected to cause global tech shortage  WePC - PC Tech & PC Gaming News
4. Logistics companies warn clients lockdown in Shenzhen will impact port activity  FreightWaves
5. Shanghai, Shenzhen keep stock markets open even amid Covid lockdowns  South China Morning Post

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Fourth shot “is necessary” Pfizer CEO says as experts monitor BA.2 - Ars Technica

1. Fourth shot “is necessary” Pfizer CEO says as experts monitor BA.2  Ars Technica
2. COVID-19 vaccine: Is a 4th dose on the way?  WFAA
3. Fully vaccinated will need fourth dose later this year, and new variant dubbed 'deltacron' detected in Europe  MarketWatch
4. Pfizer's CEO says fourth COVID-19 vaccine dose is necessary  KENS 5: Your San Antonio News Source
5. Moderna, BioNTech on the rise amid concerns over new variant, China outbreak  Seeking Alpha
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March 14, 2022 at 06:48PM Developing Predictive Indicators of Genome Stability and Cell Maturation as Measures of Cell Therapy Product Safety and Efficacy

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

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‘Stealth omicron’ prompts COVID lockdown in China - WJW FOX 8 News Cleveland

1. ‘Stealth omicron’ prompts COVID lockdown in China  WJW FOX 8 News Cleveland
2. Covid-19 cases continue to rise in China's worst outbreak since Wuhan  CNN
3. China Covid spike: Shenzhen shuts production, Shanghai closes schools  CNBC
4. China battles multiple outbreaks, driven by stealth omicron  The Associated Press - en Español
5. COVID Finally Spins Out of Control in China as New Variant Takes Hold  Yahoo News
6. View Full Coverage on Google News

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China's covid outbreak sealing provinces, threatening supply chains - The Washington Post

1. China's covid outbreak sealing provinces, threatening supply chains  The Washington Post
2. Covid-19 cases continue to rise in China's worst outbreak since Wuhan  CNN
3. China battles multiple outbreaks, driven by stealth omicron  The Associated Press - en Español
4. China Covid spike: Shenzhen shuts production, Shanghai closes schools  CNBC
5. Covid-19 Shuts Down Plants in China, Hitting Apple Supplier Foxconn, Auto Makers  The Wall Street Journal
6. View Full Coverage on Google News

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Apple supplier Foxconn pauses production in Shenzhen because of Covid outbreak - CNBC

1. Apple supplier Foxconn pauses production in Shenzhen because of Covid outbreak  CNBC
2. Apple supplier Foxconn halts operations in Shenzhen as China locks down tech hub  CNN
3. China stocks sink as Covid outbreak brings fresh lockdowns  CNBC Television
4. Seko warns clients lockdown in Shenzhen will impact port activity  FreightWaves
5. Brace yourself: Phones and other tech may become harder to get as Shenzhen goes into lockdown  XDA Developers
6. View Full Coverage on Google News

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March 14, 2022 at 02:47PM Janssen COVID-19 Vaccine

Information about the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

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Covid-19 cases continue to rise in China's worst outbreak since Wuhan - CNN

1. Covid-19 cases continue to rise in China's worst outbreak since Wuhan  CNN
2. China Covid spike: Shenzhen shuts production, Shanghai closes schools  CNBC
3. China's COVID cases more than triple to highest point in two years  New York Post
4. China battles multiple COVID-19 outbreaks, driven by stealth omicron  NPR
5. Covid-19 Shuts Down Plants in China, Hitting Apple Supplier, Auto Makers  The Wall Street Journal
6. View Full Coverage on Google News

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China Locks Down Shenzhen, Entire Jilin Province as Covid Swells - Yahoo Finance

1. China Locks Down Shenzhen, Entire Jilin Province as Covid Swells  Yahoo Finance
2. China Covid spike: Shenzhen shuts production, Shanghai closes schools  CNBC
3. China's COVID cases more than triple to highest point in two years  New York Post
4. China battles worst Covid outbreak for two years as cases double in 24 hours  The Guardian
5. Covid-19 cases continue to rise in China's worst outbreak since Wuhan  CNN
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Two of China's biggest cities impose strict COVID measures as cases accelerate | TheHill - The Hill

1. Two of China's biggest cities impose strict COVID measures as cases accelerate | TheHill  The Hill
2. Shenzhen imposes a lockdown and Shanghai restricts nonessential travel as China's new cases jump.  The New York Times
3. China battles worst Covid outbreak for two years as cases double in 24 hours  The Guardian
4. China's COVID cases more than triple to highest point in two years  New York Post
5. China Records More Local COVID Cases This Year Than in Whole of 2021  U.S. News & World Report

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China's COVID cases more than triple to highest point in two years - New York Post

1. China's COVID cases more than triple to highest point in two years  New York Post
2. China battles worst Covid outbreak for two years as cases double in 24 hours  The Guardian
3. Covid-19 Live Updates: Cases, Vaccine and Mask Mandate News  The New York Times
4. China imposes new curbs amid worst COVID outbreak in two years  Al Jazeera English
5. Access to Shanghai tightens as China’s virus cases rise  Fox News
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China battles worst Covid outbreak for two years as cases double in 24 hours - The Guardian

1. China battles worst Covid outbreak for two years as cases double in 24 hours  The Guardian
2. Covid-19 Live Updates: Mask Mandate News, Cases and Testing News  The New York Times
3. China's daily cases of symptomatic COVID more than triple  Reuters
4. China imposes new curbs amid worst COVID outbreak in two years  Al Jazeera English
5. Millions locked down as China wrestles worst virus outbreak in two years  Yahoo News

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China battles worst Covid outbreak for two years as cases double in 24 hours - The Guardian

1. China battles worst Covid outbreak for two years as cases double in 24 hours  The Guardian
2. Covid-19 Live Updates: Mask Mandate News, Cases and Testing News  The New York Times
3. China's daily cases of symptomatic COVID more than triple  Reuters.com
4. China imposes new curbs amid worst COVID outbreak in two years  Al Jazeera English
5. Millions locked down as China wrestles worst virus outbreak in two years  Yahoo News
6. View Full Coverage on Google News

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China shuts business center of Shenzhen to fight virus surge - The Associated Press - en Español

1. China shuts business center of Shenzhen to fight virus surge  The Associated Press - en Español
2. China battles worst Covid outbreak for two years as cases double in 24 hours  The Guardian
3. Shanghai restricts travel further as China's new cases double.  The New York Times
4. China's virus cases rise, access to Shanghai tightened  The Associated Press - en Español
5. China reinstates COVID-19 restrictions amid a rise in infections | TheHill  The Hill
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China daily local symptomatic COVID cases more than triple - Reuters

1. China daily local symptomatic COVID cases more than triple  Reuters
2. Shanghai restricts travel further as China's new cases double.  The New York Times
3. China battles worst Covid outbreak for two years as cases double in 24 hours  The Guardian
4. China's virus cases rise, access to Shanghai tightened  The Associated Press - en Español
5. China reinstates COVID-19 restrictions amid a rise in infections | TheHill  The Hill

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China battles worst Covid outbreak for two years as cases double in 24 hours - The Guardian

1. China battles worst Covid outbreak for two years as cases double in 24 hours  The Guardian
2. Shanghai restricts travel further as China's new cases double.  The New York Times
3. China Daily Local Symptomatic COVID Cases More Than Triple  U.S. News & World Report
4. Covid-19 Pandemic: Live Updates and News for Mar. 13, 2022  Bloomberg
5. China reinstates COVID-19 restrictions amid a rise in infections | TheHill  The Hill
6. View Full Coverage on Google News

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China daily local COVID cases hit two-year high of over 1500 - Reuters

1. China daily local COVID cases hit two-year high of over 1500  Reuters
2. Covid Updates: China Dismisses 2 Mayors and Shanghai Closes Schools as Case Numbers Rise  The New York Times
3. China tightens controls as more virus cases reported  ABC News
4. China locks down city of 9 million amid new spike in cases  The Associated Press - en Español
5. Students trapped in quarantine beg for help online as China faces biggest Covid outbreak since 2020  CNN
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China locks down city of 9 million amid new spike in COVID cases - WOODTV.com

1. China locks down city of 9 million amid new spike in COVID cases  WOODTV.com
2. Covid Updates: China Dismisses 2 Mayors and Shanghai Closes Schools as Case Numbers Rise  The New York Times
3. China locks down city of 9 million amid new spike in cases  The Associated Press - en Español
4. Students trapped in quarantine beg for help online as China faces biggest Covid outbreak since 2020  CNN
5. New China COVID-19 wave biggest since 2020 Wuhan outbreak  Deseret News

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March 11, 2022 at 10:32PM FDA Roundup: March 11, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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March 11, 2022 at 09:34PM Q&A for Spikevax (COVID-19 Vaccine mRNA)

Q&A document with information about FDA's recent approval of Moderna's Spikevax (COVID-19 Vaccine, mRNA).

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March 11, 2022 at 04:04PM Vivaglobin

Product approval information is indicated for treatment of patients with primary immune deficiency (PID.

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March 10, 2022 at 04:54PM FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options

FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options

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March 10, 2022 at 04:48PM You Spoke, FDA Listened: New Patient Engagement Collaborative, Call for Nominations

The FDA is committed to collaborating with patients, caregivers, and advocates, as well as incorporating the various perspectives from these groups into the FDA’s regulatory decision-making processes.

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March 10, 2022 at 04:44PM FDA Blood Supply and Demand Simulation Model Could Help Nation Prepare for Emergencies

FDA Blood Supply and Demand Simulation Model Could Help Nation Prepare for Emergencies

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March 10, 2022 at 04:21PM Predicting Stem Cell Activity to Ensure Safe and Effective Therapies

Predicting Stem Cell Activity to Ensure Safe and Effective Therapies

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March 10, 2022 at 04:11PM FDA Budget Matters: A Cross-Cutting Data Enterprise for Real World Evidence

FDA Budget Matters: A Cross-Cutting Data Enterprise for Real World Evidence

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March 10, 2022 at 04:10PM FDA Budget Matters: Investing in Advanced Domestic Manufacturing

FDA Budget Matters: Investing in Advanced Domestic Manufacturing

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March 10, 2022 at 03:53PM Protecting and Promoting Public Health: Advancing the FDA’s Medical Countermeasures Mission

Protecting and Promoting Public Health: Advancing the FDA’s Medical Countermeasures Mission

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March 10, 2022 at 03:10PM FDA Protecting the Nation Through Medical Countermeasures

The FDA works closely with the U.S. Department of Defense to promote the development and availability of medical countermeasures to support the American military personnel’s unique needs. Learn about medical countermeasures, what they are and how they impact public health.

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March 09, 2022 at 05:47PM FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers - 03/23/2022

The FDA Center for Drug Evaluation and Research and the FDA Biomarker Working Group will convene a virtual workshop on March 23-24, 1-3 PM (EST) entitled “Identification of Concepts and Terminology for Multi-Component Biomarkers”. The workshop is intended to develop multi-component biomarker concepts and terminology to identify areas of conceptual

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March 09, 2022 at 05:27PM Section 8000: General Information

This is the main page for CBER's SOPP Section 8000: General Information.

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March 09, 2022 at 03:00PM Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry

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March 09, 2022 at 02:20PM Cellular, Tissue, and Gene Therapies Advisory Committee March 10, 2022 Meeting Announcement - 03/10/2022

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee March 10, 2022 Meeting Announcement.

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March 08, 2022 at 05:31PM Innovative Regenerative Medicine Therapies – Patient Safety Comes First

Cellular-derived therapies, including stem cell-based products, offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist.

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March 08, 2022 at 05:26PM FDA’s Budget: Data Modernization and Enhanced Technologies

FDA’s FY 2022 Budget includes funding for an agency-wide data modernization and enhanced technologies initiative that supports both food safety and medical product safety programs.

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March 08, 2022 at 05:19PM 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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March 08, 2022 at 05:16PM 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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March 08, 2022 at 05:14PM 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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March 08, 2022 at 05:07PM 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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March 08, 2022 at 04:29PM Fulfilling Essential Public Health Needs in 2022

The FDA’s public health mission, although most apparent during emergencies, is actually in operation every day of every year, protecting the American public from many threats.

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March 08, 2022 at 04:27PM Many Important Drugs Approved in 2021 as COVID-19 Pandemic Continues

CDER approved a wide variety of safe and effective new drug therapies in 2021 despite challenges brought on by the ongoing COVID-19 pandemic.

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March 07, 2022 at 07:39PM Virus Entry and Its Inhibition by Antibodies: Studies to Aid the Development and Evaluation of Vaccines that Protect against Viral Infectious Diseases

A description of Carol Weiss's research program and related publications.

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March 07, 2022 at 05:42PM Section 8400: Marketing Applications

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

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March 07, 2022 at 03:56PM RAPLIXA

Product approval information is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

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March 04, 2022 at 06:13PM Profilnine SD - Factor IX Complex

Product approval information is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B.

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Tornado outbreak kills at least seven in Iowa with severe damage near Des Moines area - The Washington Post

1. Tornado outbreak kills at least seven in Iowa with severe damage near Des Moines area  The Washington Post
2. Iowa Tornadoes: Survivors Describe Storms, Aftermath | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
3. Tornadoes kill 7, including 2 children, near Des Moines, Iowa, officials say  CNN
4. Officials identify 6 killed in Madison County tornado outbreak  KCCI Des Moines
5. Central and southeastern Iowa could see snow Sunday night. Here's what to expect  Des Moines Register
6. View Full Coverage on Google News

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Tornadoes kill 7, including 2 children, near Des Moines, Iowa, officials say - CNN

1. Tornadoes kill 7, including 2 children, near Des Moines, Iowa, officials say  CNN
2. Iowa Tornadoes: Survivors Describe Storms, Aftermath | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
3. Tornadoes rip through parts of Iowa, killing at least 7 | USA TODAY  USA TODAY
4. Officials identify 6 killed in Madison County tornado outbreak  KCCI Des Moines
5. Central and southeastern Iowa could see snow Sunday night. Here's what to expect  Des Moines Register
6. View Full Coverage on Google News

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Tornado kills 7, including 2 children, near Des Moines, Iowa, officials say - CNN

1. Tornado kills 7, including 2 children, near Des Moines, Iowa, officials say  CNN
2. Iowa Tornadoes Kill 7, Cause Widespread Damage | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
3. 6 dead as large tornado roars through central Iowa  WTVR CBS 6
4. Multiple deaths confirmed in Madison County after tornado outbreak  KCCI Des Moines
5. Several people killed after possible tornado touches down in Iowa  WHAS11

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Multiple deaths confirmed in Madison County after tornado outbreak - KCCI Des Moines

1. Multiple deaths confirmed in Madison County after tornado outbreak  KCCI Des Moines
2. Tornado kills 7, including 2 children, near Des Moines, Iowa, officials say  CNN
3. Buildings Ripped Apart by Tornadoes in Iowa | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
4. Update: Seven now dead after evening tornadoes | Top Stories  kwwl.com
5. Several people killed after possible tornado touches down in Iowa  WHAS11
6. View Full Coverage on Google News

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Iowa tornado leaves at least 6 dead, including 2 children - New York Post

1. Iowa tornado leaves at least 6 dead, including 2 children  New York Post
2. Tornado kills 6, including 2 children, near Des Moines, Iowa, officials say  CNN
3. Buildings Ripped Apart by Tornadoes in Iowa | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
4. Multiple deaths confirmed in Madison County after tornado outbreak  KCCI Des Moines
5. Several people killed after possible tornado touches down in Iowa  WHAS11
6. View Full Coverage on Google News

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Iowa Tornadoes Kill 7, Cause Widespread Damage | The Weather Channel - Articles from The Weather Channel | weather.com - The Weather Channel

1. Iowa Tornadoes Kill 7, Cause Widespread Damage | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
2. Tornado kills 6, including 2 children, near Des Moines, Iowa, officials say  CNN
3. Several people killed after possible tornado touches down in Iowa  WHAS11
4. Multiple deaths confirmed in Madison County after tornado outbreak  KCCI Des Moines
5. Buildings Ripped Apart by Tornadoes in Iowa | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
6. View Full Coverage on Google News

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