May 31, 2024 at 09:21PM FDA Roundup: May 31, 2024

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

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May 31, 2024 at 07:03PM JYNNEOS

Indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.


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May 31, 2024 at 04:17PM CBER Rare Disease Program

Description of CBER's Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions.

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May 31, 2024 at 03:31PM Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program

Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program

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Third person in US tests positive for bird flu in connection to outbreak in dairy cattle - CNN

1. Third person in US tests positive for bird flu in connection to outbreak in dairy cattle  CNN
2. A Third Person in the U.S. Has Bird Flu. This Time, It's Different  TIME
3. Bird flu infects third US dairy worker; Michigan set to expand testing  Reuters
4. CDC says third person infected with bird flu — with a new symptom  NBC News
5. Bird Flu Has Infected a Third U.S. Farmworker  The New York Times

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May 30, 2024 at 08:05PM POSTPONED- Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement - 02/15/2022

This the CBER Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement

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May 30, 2024 at 05:52PM COVID-19 Vaccines

FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.

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May 30, 2024 at 02:57PM FDA Zika virus reference panel for molecular-based diagnostic devices supports product testing for Emergency Use Authorization and 510(k) submissions

Summary of research article for posting on CBER Innovation web site

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May 29, 2024 at 11:01PM CBER 2024 Orphan Approvals (new BLAs)

CBER 2024 Orphan Approvals

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May 29, 2024 at 04:10PM Potential vCJD Risk From US Licensed Plasma-Derived Factor VIII (pdFVIII, Antihemophilic Factor) Products: Summary Information, Key Points

In recent years, questions have been raised concerning the potential risk of variant Creutzfeldt-Jakob disease (vCJD - a rare but fatal brain infection) for recipients of plasma- derived clotting factors

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Farmers must kill 4.2 million chickens after bird flu hits Iowa egg farm - The Associated Press

1. Farmers must kill 4.2 million chickens after bird flu hits Iowa egg farm  The Associated Press
2. Farmers must kill 4.2M chickens after bird flu hits Iowa egg farm  NBC News
3. 4.2M Chickens Must Be Killed After Bird Flu Hits Iowa Farm  TIME
4. US Records Worst Bird Flu Outbreak in Two Years at Iowa Egg Farm  Bloomberg
5. Bird flu strikes flock of 4.2 million chickens in Sioux County  KCCI Des Moines

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Deadly Tornadoes Destroy Bentonville Trails and Flatten Bike Fest - Singletracks.com

1. Deadly Tornadoes Destroy Bentonville Trails and Flatten Bike Fest  Singletracks.com
2. Tornado Devastates Arkansas Town  The New York Times
3. Arkansas Division of Emergency Management revises death count of northwest Arkansas tornado outbreak from eight deaths to seven  Yahoo! Voices
4. Rogers High School offering assistance to storm victims  4029tv
5. NWS releases preliminary report on deadly Arkansas tornadoes  KFSM 5Newsonline

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At least 2000 feared dead in Papua New Guinea landslide. These are some challenges rescuers face - The Associated Press

1. At least 2000 feared dead in Papua New Guinea landslide. These are some challenges rescuers face  The Associated Press
2. Papua New Guinea Landslide May Have Buried 2,000 People - Videos from The Weather Channel  The Weather Channel
3. Fears rise a second landslide and disease outbreak loom at site of Papua New Guinea disaster  The Associated Press
4. More than 2,000 believed buried alive in Papua New Guinea landslide, government says  CBS News
5. Satellite imagery shows landslide that is believed to have buried thousands in Papua New Guinea  Fox Weather

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Papua New Guinea Landslide Has Buried 2000 People, Officials Say - The New York Times

1. Papua New Guinea Landslide Has Buried 2000 People, Officials Say  The New York Times
2. Papua New Guinea Landslide May Have Buried 2,000 People - Videos from The Weather Channel  The Weather Channel
3. Fears rise a second landslide and disease outbreak loom at site of Papua New Guinea disaster  Yahoo! Voices
4. PNG landslide: More than 2,000 killed, government says  The Associated Press
5. Papua New Guinea landslide: the search for survivors – in pictures  The Guardian

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At least 8 dead after tornado outbreak in Arkansas, Biden tells gov. feds ready to assist - WKRC TV Cincinnati

1. At least 8 dead after tornado outbreak in Arkansas, Biden tells gov. feds ready to assist  WKRC TV Cincinnati
2. Deadly Tornado Leaves Rogers, Arkansas, 'Unrecognizable' - Videos from The Weather Channel  The Weather Channel
3. NWS: Centerton, Decatur tornadoes confirmed as EF2, EF3  Yahoo! Voices
4. Gov. Sanders, Rep. Womack, Sen. Boozman in Rogers touring storm damage  4029tv
5. One confirmed death in Northeast Arkansas following storms  KAIT

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Severe weather threat brings chance for hail, strong winds, tornadoes - WLWT Cincinnati

1. Severe weather threat brings chance for hail, strong winds, tornadoes  WLWT Cincinnati
2. Severe Weather Outbreak Shifts East For Memorial Day Weekend - Videos from The Weather Channel  The Weather Channel
3. FIRST ALERT - Rounds of strong storms expected through early Monday morning  WBKO
4. Tornadoes and flooding possible in Louisville, southern Indiana  WHAS11.com
5. FIRST ALERT ACTION DAY today due to severe weather, possible tornadoes  KFVS

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At least 6 people are dead after tornado-spawning storms strike the Central US Memorial Day weekend - CNN

1. At least 6 people are dead after tornado-spawning storms strike the Central US Memorial Day weekend  CNN
2. Texas Tornado Kills At Least 5 In Valley View - Videos from The Weather Channel  The Weather Channel
3. At least 7 dead in Texas, Oklahoma and Arkansas after severe weather roars across region  KXAN.com
4. At least 5 dead, dozens injured in reported tornado outbreak in Cooke, Denton counties  FOX 4 News Dallas-Fort Worth
5. 5 dead, dozens injured after apparent tornado tears through Texas, sheriff says  ABC News

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At least five people are dead after tornado-spawning storms strike Texas and Oklahoma Memorial Day weekend - CNN

1. At least five people are dead after tornado-spawning storms strike Texas and Oklahoma Memorial Day weekend  CNN
2. At least 5 dead, dozens injured in reported tornado outbreak in Cooke, Denton counties  FOX 4 News Dallas-Fort Worth
3. Valley View Texas Tornado Kills At Least 5 - Videos from The Weather Channel  The Weather Channel
4. Death toll rising after tornadoes rock America's Heartland over Memorial Day weekend  Fox Weather
5. Five dead, major storm damage in Cooke and Denton counties after tornado warning Saturday  NBC DFW

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Severe weather outbreak slams Plains, from Kansas into Oklahoma, with "intense" tornadoes - Axios

1. Severe weather outbreak slams Plains, from Kansas into Oklahoma, with "intense" tornadoes  Axios
2. Weather Service issues ‘particularly dangerous situation’ tornado watch for parts of Texas, Oklahoma and Kansas  CNN
3. Tornado warning issued for parts of Oklahoma amid severe storms as heat scorches South Texas   The Atlanta Journal Constitution
4. Millions face threat of tornadoes, hail and heavy rainfall through Memorial Day weekend  Fox Weather
5. Saturday storms brought large hail, tornadoes to Oklahoma  KOCO Oklahoma City

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May 24, 2024 at 08:45PM FDA Roundup: May 24, 2024

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

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May 24, 2024 at 06:09PM Cleared 510(k) Submissions with Supporting Documents

Listing of cleared 510(k) submissions with supporting documents. Information is reflected as of the clearance date.

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May 24, 2024 at 04:00PM 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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May 22, 2024 at 10:43PM Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Announcement - 06/05/2024

This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) June 5, 2024 Meeting announcement and meeting materials.

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Rounds Of Severe Weather Continue Through Weekend | Weather.com - The Weather Channel

1. Rounds Of Severe Weather Continue Through Weekend | Weather.com  The Weather Channel
2. Severe Weather Possible Again Today - Videos from The Weather Channel  The Weather Channel
3. First Alert: Severe storms possible with unsettled pattern the next several days  KFVS
4. Outbreak of severe thunderstorms predicted for large areas of the US  The Guardian US
5. Video At least 5 states face threats of strong tornadoes  ABC News

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May 21, 2024 at 10:26PM FDA Roundup: May 21, 2024

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

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Dangerous storms threaten central states this week, especially Tuesday - The Washington Post

1. Dangerous storms threaten central states this week, especially Tuesday  The Washington Post
2. Millions face severe weather threat Monday as storms target Great Lakes, central US  Fox Weather
3. Severe Weather Outbreak Continues In Plains, Midwest  The Weather Channel
4. Central US eyes back-to-back days of powerful storms, tornadoes and hail  Yahoo! Voices
5. Weather tracker: Tornado and hail risk as US storm season ramps up again  The Guardian

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May 21, 2024 at 01:00AM Withdrawn Guidances (Biologics)

This page displays withdrawn CBER guidance documents

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May 21, 2024 at 12:52AM Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Communicable Disease Agent or Disease

This is the Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Communicable Disease Agent or Disease page

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Millions face severe weather threat Monday as storms target Great Lakes, central US - Fox Weather

1. Millions face severe weather threat Monday as storms target Great Lakes, central US  Fox Weather
2. Severe Weather Outbreak Continues In Plains, Midwest  The Weather Channel
3. Storm Track 3 Forecast: Storms northwest tonight, another round for Tuesday  KSN-TV
4. Weather tracker: Tornado and hail risk as US storm season ramps up again  The Guardian
5. Central US eyes back-to-back days of powerful storms, tornadoes and hail  Yahoo! Voices

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May 20, 2024 at 07:59PM Improvement of Biological Product Quality by Application of New Technologies to Characterize of Vaccines and Blood Products: NMR Spectroscopy and Light Scattering

A description of Daron Freedberg's research program and related publications.

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May 20, 2024 at 07:50PM FDA Promotes Clinical Trial Innovation

As the U.S. Food and Drug Administration observes Clinical Trials Day, we reflect on the progress made and the widespread efforts underway to advance clinical trial innovation.

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May 17, 2024 at 11:30PM 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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May 17, 2024 at 09:46PM FDA Roundup: May 17, 2024

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

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May 16, 2024 at 10:50PM FDALabel: Full-Text Search of Drug Product Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

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May 15, 2024 at 04:02PM Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products

This is the draft guidance Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products

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May 15, 2024 at 03:35PM Protecting and Advancing the Health of Women Through Policy, Research, Education and Outreach

Since its inception in 1994, OWH has been at the forefront of ensuring that the unique health needs of women are prioritized through a multifaceted approach that encompasses policy, research, education, and outreach.

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May 15, 2024 at 12:44PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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May 08, 2024 at 08:31PM Supporting the Production of Safe and Effective Influenza Vaccines

A description of Zhiping Ye's research program and related publications.

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May 08, 2024 at 08:29PM Influenza neuraminidase antigenicity and efficacy in vaccines

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

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May 13, 2024 at 09:23PM Vaccines Research

List of Vaccines Research.

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May 13, 2024 at 07:10PM POSTPONED - Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement - 05/16/2024

This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) May 16, 2024 Meeting announcement and meeting materials.

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May 10, 2024 at 10:10PM Biological Product Deviation Reports Annual Summaries

Biological Product Deviation Reports Annual Summaries

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May 10, 2024 at 09:37PM 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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May 10, 2024 at 04:32PM Devices Guidances

This page lists Medical Device Guidance documents.

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May 09, 2024 at 08:18PM FDA Roundup: May 7, 2024

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

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Tornadoes, severe storms leave 3 dead in Tennessee, North Carolina as damage trail stretches 900 miles - Fox Weather

1. Tornadoes, severe storms leave 3 dead in Tennessee, North Carolina as damage trail stretches 900 miles  Fox Weather
2. Severe Weather Tennesee | News | goskagit.com  goskagit.com
3. Tornadoes tear through the southeastern U.S. as storms leave 3 dead  NPR
4. Severe Weather Outbreak Live Updates  The Weather Channel
5. BLOG: Damage, power outages after severe storms occur across Tennessee Valley  WHNT News 19

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May 08, 2024 at 10:29PM Administrative Guidances

This page lists Administrative Guidance documents.

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May 08, 2024 at 03:20PM COVID-19 Vaccines

FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.

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Tornadoes reported in west Michigan; multiple buildings in Portage damaged: Live updates - Detroit Free Press

1. Tornadoes reported in west Michigan; multiple buildings in Portage damaged: Live updates  Detroit Free Press
2. Portage asks residents in storm-damaged areas to stay home Wednesday, 2 shelters open  MLive.com
3. Tornado-warned storms cause significant damage in Michigan as multiday severe weather outbreak continues  Fox Weather
4. Michigan Tornado Damages FedEx Facility | Weather.com  The Weather Channel
5. Michigan Gov. Gretchen Whitmer declares state of emergency in parts of state over tornadoes  Yahoo! Voices

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May 07, 2024 at 10:37PM FDALabel: Full-Text Search of Drug Product Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

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May 07, 2024 at 10:09PM FDA Roundup: May 7, 2024

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

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May 07, 2024 at 08:42PM CBER 2024 Orphan Approvals (new BLAs)

CBER 2024 Orphan Approvals

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May 07, 2024 at 04:23PM Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Inspection Information

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

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UPDATES: Tornado warning issued for Oklahoma counties - KOCO Oklahoma City

1. UPDATES: Tornado warning issued for Oklahoma counties  KOCO Oklahoma City
2. 'High risk': Tornado outbreak expected in central U.S. today  USA TODAY
3. Millions face threat of violent storms, tornadoes across Plains  CBS News
4. Rare 'High Risk' severe weather threat covers Oklahoma, Kansas ahead of expected tornado outbreak Monday  Fox Weather
5. Severe storms underway in rare 'high risk' for tornadoes in Central US  CNN

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Severe weather leaves millions at risk as storms sweep across the South - NBC News

1. Severe weather leaves millions at risk as storms sweep across the South  NBC News
2. Rare 'High Risk' severe weather threat covers Oklahoma, Kansas ahead of expected tornado outbreak Monday  Fox Weather
3. Storm Blog: Severe weather returns to Oklahoma in May  KFOR Oklahoma City
4. 'High risk': Tornado outbreak expected in central U.S. today  USA TODAY
5. Severe storms underway in rare 'high risk' for tornadoes in Central US  CNN

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'High risk': Tornado outbreak expected in central U.S. today - USA TODAY

1. 'High risk': Tornado outbreak expected in central U.S. today  USA TODAY
2. Highest-Level Severe Weather Threat Issued For Plains - Videos from The Weather Channel  The Weather Channel
3. Severe storms are firing up on rare 'high risk' day for tornadoes in Central US  CNN
4. Millions of people across Oklahoma, southern Kansas at risk of tornadoes and severe thunderstorms  WPRI.com
5. Oklahoma to see high risk of storms with possible tornadoes  KOCO Oklahoma City

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UPDATES: Oklahoma to see high risk of severe storms with big tornado threat today - KOCO Oklahoma City

1. UPDATES: Oklahoma to see high risk of severe storms with big tornado threat today  KOCO Oklahoma City
2. Severe Weather Live Updates  The Weather Channel
3. Significant tornado outbreak possible in Central US  CNN
4. "High risk" for severe storms, tornadoes across Plains, Central U.S.  Axios
5. Millions of people across Oklahoma, southern Kansas at risk of tornadoes and severe thunderstorms  ABC News

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Severe storms, tornadoes threaten 40 million across Plains, Central U.S., Ohio Valley - Axios

1. Severe storms, tornadoes threaten 40 million across Plains, Central U.S., Ohio Valley  Axios
2. Severe weather outbreak could threaten millions in central US on Monday  Fox Weather
3. TIMELINE: Oklahoma to see significant risk of severe storms today  KOCO Oklahoma City
4. Severe Weather Outbreak Packs Tornado Threat  The Weather Channel
5. Oklahoma and Kansas Face Severe Weather Threat, Including Tornadoes  The New York Times

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Why Biden finally decided to speak out on college protest violence - POLITICO

1. Why Biden finally decided to speak out on college protest violence  POLITICO
2. Biden brings up Islamophobia amid the worst antisemitism outbreak in decades  Fox News
3. Biden cannot afford a boiling summer of protest  CNN
4. The Protesters and the President  The New York Times
5. Biden says Americans have 'right to protest, but not the right to chaos' on college campuses after another night of mass arrests. Here are the latest updates.  Yahoo! Voices

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Why Biden finally decided to speak out on college protest violence - POLITICO

1. Why Biden finally decided to speak out on college protest violence  POLITICO
2. Biden brings up Islamophobia amid the worst antisemitism outbreak in decades  Fox News
3. The Protesters and the President  The New York Times
4. Biden cannot afford a boiling summer of protest  CNN
5. Biden says Americans have 'right to protest, but not the right to chaos' on college campuses after another night of mass arrests. Here are the latest updates.  Yahoo! Voices

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Why Biden finally decided to speak out on college protest violence - POLITICO

1. Why Biden finally decided to speak out on college protest violence  POLITICO
2. Biden, Congressional Democrats distance themselves from campus protests - The Washington Post  The Washington Post
3. Biden brings up Islamophobia amid the worst antisemitism outbreak in decades  Fox News
4. The Protesters and the President  The New York Times
5. Biden Looks for Balance Amid Campus Protests Over Gaza  Bloomberg

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May 03, 2024 at 09:08PM Biomarker-driven Drug Development for Allergic Diseases and Asthma; Public Workshop - 02/22/2024

This public workshop is intended to be a forum for the exchange of information and perspectives among regulators and academic investigators on the use of biomarkers to monitor, predict efficacy, and evaluate responses to novel therapeutics for allergic diseases.

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Biden tries threading the needle on campus protests, war - Axios

1. Biden tries threading the needle on campus protests, war  Axios
2. Biden cannot afford a boiling summer of protest  CNN
3. Biden ripped for Islamophobia remarks amid antisemitism outbreak and more top headlines  Fox News
4. The Protesters and the President  The New York Times
5. Why Biden decided to speak out about the campus protests after days of silence  NBC News

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Biden Slammed for Being 'Authoritarian' After Protest Comments - Newsweek

1. Biden Slammed for Being 'Authoritarian' After Protest Comments  Newsweek
2. Biden brings up Islamophobia amid the worst antisemitism outbreak in decades  Fox News
3. The Protesters and the President  The New York Times
4. Biden cannot afford a boiling summer of protest  CNN
5. Nearly half of NYC arrests involved people not affiliated with schools  NBC News

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May 02, 2024 at 03:50PM Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs

This guidance provides recommendations to you, a blood establishment, for obtaining written informed consent from a prospective Source Plasma donor participating in a plasmapheresis program or an immunization program.

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May 02, 2024 at 03:42PM Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry, cell, tissue, cellular, hct/p, donor, guidance, donor eligibility, donor testing, blood, hiv, hbv, hcv, cjd, tse

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May 02, 2024 at 03:32PM Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms

This is the Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms.

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Walnuts Recalled From Whole Foods After E. Coli Outbreak - The New York Times

1. Walnuts Recalled From Whole Foods After E. Coli Outbreak  The New York Times
2. FDA says multistate E. coli outbreak tied to walnuts  Fox Business
3. California company recalls shelled walnuts linked to outbreak of E. coli infections  Food Safety News
4. Walnuts Recalled Nationwide Due to E. Coli Outbreak  EatingWell
5. Organic walnuts E. Coli alert: 7 hospitalized by recalled bulk nuts that may have been sold in over 300 stores  Fast Company

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May 01, 2024 at 08:24PM ADSTILADRIN

For the treatment of High-grade, Bacillus Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer.

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