Boar's Head plant had dozens of violations, dubbed 'listeria factory' by lawyer - Fox Business

1. Boar's Head plant had dozens of violations, dubbed 'listeria factory' by lawyer  Fox Business
2. These are the Boar’s Head deli meats recalled amid the listeria outbreak  Yahoo! Voices
3. Boar’s Head Plant Tied to 9 Listeria Deaths Had Mold, Leaky Pipes and Flies  The New York Times
4. What to know about the listeria outbreak that has left 57 sick, 9 dead  ABC News
5. Virginia Boar’s Head plant linked to deadly outbreak broke food safety rules dozens of times, records show  The Virginian-Pilot

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Boar's Head plant had dozens of violations, dubbed 'listeria factory' by lawyer - Fox Business

1. Boar's Head plant had dozens of violations, dubbed 'listeria factory' by lawyer  Fox Business
2. Boar’s Head Plant Tied to 9 Listeria Deaths Had Mold, Leaky Pipes and Flies  The New York Times
3. These are the Boar’s Head deli meats recalled amid the listeria outbreak  The Washington Post
4. What to know about the listeria outbreak that has left 57 sick, 9 dead  ABC News
5. Bugs, mold and mildew found in Boar's Head plant linked to deadly listeria outbreak  CBS News

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Israel-Gaza war: UN agencies start rollout of Gaza polio vaccines - BBC.com

1. Israel-Gaza war: UN agencies start rollout of Gaza polio vaccines  BBC.com
2. Polio vaccine campaign begins in Gaza a day before fighting is expected to pause  The Associated Press
3. As polio vaccinations begin in Gaza, U.N. says success hinges on a pause in fighting  NPR
4. Polio vaccinations arrive in Gaza, but the sanitation crisis remains  NBC News
5. Behind Gaza polio case, experts see ‘horrible’ WHO decision fueling outbreaks worldwide  The Times of Israel

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Amid Boar's Head listeria outbreak, experts say be cautious of other deli foods - Scripps News

1. Amid Boar's Head listeria outbreak, experts say be cautious of other deli foods  Scripps News
2. Boar’s Head Plant Tied to 9 Listeria Deaths Had Mold, Leaky Pipes and Flies  The New York Times
3. Bugs, mold and mildew found in Boar's Head plant linked to deadly listeria outbreak  CBS News
4. 9 dead, 57 hospitalized in listeria outbreak linked to Boar’s Head deli meat  Good Morning America
5. What to know about the listeria outbreak that has left 57 sick, 9 dead  ABC News

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Amid Boar's Head listeria outbreak, experts say be cautious of other deli foods - Scripps News

1. Amid Boar's Head listeria outbreak, experts say be cautious of other deli foods  Scripps News
2. Boar’s Head Plant Tied to 9 Listeria Deaths Had Mold, Leaky Pipes and Flies  The New York Times
3. Bugs, mold and mildew found in Boar's Head plant linked to deadly listeria outbreak  CBS News
4. These are the Boar’s Head deli meats recalled amid the listeria outbreak  The Washington Post
5. What to know about the listeria outbreak that has left 57 sick, 9 dead  ABC News

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Amid Boar's Head listeria outbreak, experts say be cautious of other deli foods - Scripps News

1. Amid Boar's Head listeria outbreak, experts say be cautious of other deli foods  Scripps News
2. Boar’s Head Plant Tied to 9 Listeria Deaths Had Mold, Leaky Pipes and Flies  The New York Times
3. Boar's Head plant linked to deadly outbreak broke food safety rules dozens of times, records show  WVTM13 Birmingham
4. Bugs, mold and mildew found in Boar's Head plant linked to deadly listeria outbreak  CBS News
5. These are the Boar’s Head deli meats recalled amid the listeria outbreak  The Washington Post

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UN to vaccinate Gaza's children against polio during pauses in fighting - Reuters

1. UN to vaccinate Gaza's children against polio during pauses in fighting  Reuters
2. Gaza Faces Polio Threat After 11 Months of War  The New York Times
3. 'Complex and dangerous operation': Massive Polio vaccination campaign in Gaza to begin Sunday  MSNBC
4. Video: Health officials request pause in Gaza fighting to administer polio vaccines  CNN
5. Behind Gaza polio case, experts see ‘horrible’ WHO decision fueling outbreaks worldwide  The Times of Israel

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Israel agrees to pauses in fighting for Gaza polio vaccine drive - BBC.com

1. Israel agrees to pauses in fighting for Gaza polio vaccine drive  BBC.com
2. Why Relief Agencies Are Rushing Polio Vaccines to Gaza  The New York Times
3. Israel war on Gaza updates: Israel agrees limited ‘pauses’ for vaccinations  Al Jazeera English
4. Gaza’s Polio Outbreak Won’t Spare Israelis  Foreign Policy
5. Israel agrees 'pauses' in Gaza assault to allow polio vaccination campaign  Middle East Eye

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Blood, bugs and mold found in Boar's Head plant linked to listeria outbreak that's killed at least 9 people - New York Post

1. Blood, bugs and mold found in Boar's Head plant linked to listeria outbreak that's killed at least 9 people  New York Post
2. Bugs, mold and mildew found in Boar's Head plant linked to deadly listeria outbreak  CBS News
3. Mold, bugs found at Va. Boar’s Head facility tied to listeria outbreak  The Washington Post
4. Insects, mold and puddles of blood found at Boar's Head plant linked to listeria outbreak, records show  NBC News
5. 9 deaths, 57 hospitalizations reported from listeria outbreak linked to Boar's Head deli meat recall  ABC News

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Israel agrees to pauses in fighting for Gaza polio vaccine drive - BBC.com

1. Israel agrees to pauses in fighting for Gaza polio vaccine drive  BBC.com
2. Video: Health officials request pause in Gaza fighting to administer polio vaccines  CNN
3. Polio vaccination to begin on Sunday amid limited pause in fighting: WHO  Al Jazeera English
4. Middle East Crisis Israel Agrees to Staggered Pauses in Fighting to Allow for Polio Vaccination, U.N. Says  The New York Times
5. Behind Gaza polio case, experts see ‘horrible’ WHO decision fueling outbreaks worldwide  The Times of Israel

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August 29, 2024 at 11:24PM ELEVIDYS

Treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

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Check your fridge: CDC warns against eating recalled deli meat as deadly listeria outbreak expands - CNN

1. Check your fridge: CDC warns against eating recalled deli meat as deadly listeria outbreak expands  CNN
2. Bugs, mold and mildew found in Boar's Head plant linked to deadly listeria outbreak  CBS News
3. 9 people have died in connection to the listeria outbreak among Boar's Head products  NPR
4. 5 More People Die From Listeria Linked to Boar’s Head Meats, C.D.C. Says  The New York Times
5. Death toll rises to 9 in Boar’s Head-linked listeria outbreak, CDC says  The Washington Post

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New Mexico woman dead after Boar’s Head listeria outbreak - KOB 4

1. New Mexico woman dead after Boar’s Head listeria outbreak  KOB 4
2. Bugs, mold and mildew found in Boar's Head plant linked to deadly listeria outbreak  CBS News
3. 9 people have died in connection to the listeria outbreak among Boar's Head products  NPR
4. Check your fridge: CDC warns against eating recalled deli meat as deadly listeria outbreak expands  CNN
5. 5 More People Die From Listeria Linked to Boar’s Head Meats, C.D.C. Says  The New York Times

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Bugs, mold and mildew found in Boar's Head plant linked to deadly listeria outbreak - CBS News

1. Bugs, mold and mildew found in Boar's Head plant linked to deadly listeria outbreak  CBS News
2. Check your fridge: CDC warns against eating recalled deli meat as deadly listeria outbreak expands  CNN
3. Listeria outbreak linked to deli meats claims five more lives, CDC says  Reuters
4. Boar's Head recall: 2 deaths in South Carolina among 8 linked to listeria outbreak  WRAL News
5. 2 SC deaths may be linked to a national contaminated deli meat outbreak  The Post and Courier

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Six more deaths linked to Boar’s Head deli meat listeria outbreak - NBC News

1. Six more deaths linked to Boar’s Head deli meat listeria outbreak  NBC News
2. Bugs, mold and mildew found in Boar's Head plant linked to deadly listeria outbreak  CBS News
3. 9 people now dead from listeria outbreak tied to Boar's Head deli meats  FOX 13 Tampa
4. 5 More People Die From Listeria Linked to Boar’s Head Meats, C.D.C. Says  The New York Times
5. Check your fridge: CDC warns against eating recalled deli meat as deadly listeria outbreak expands  CNN

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August 28, 2024 at 08:33PM What Does FDA Approve? Part 2

The growing spread of rumors, misinformation and disinformation about science, medicine, and the FDA, is putting patients and consumers at risk. FDA is here to provide the facts.

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August 28, 2024 at 05:17PM Industry Frequently Asked Questions

Frequently asked questions and the associated answers sorted by topic area

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August 28, 2024 at 03:10PM Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

The guidance is intended to help manufacturers understand the VMSR program. The guidance further explains, but does not change, the conditions of the program.

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August 27, 2024 at 09:08PM FDA Roundup: August 27, 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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August 27, 2024 at 03:20PM CARsgen Therapeutics Corporation - 686504 - 07/26/2024

CGMP/Finished Pharmaceuticals/Adulterated

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August 26, 2024 at 09:51PM 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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August 26, 2024 at 07:49PM MACI (autologous cultured chondrocytes on porcine collagen membrane)

MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults.

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August 26, 2024 at 02:38PM Vaccines Licensed for Use in the United States

The product name and trade name of vaccines licensed for use in the United States.

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August 23, 2024 at 10:05PM 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 150,000 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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August 23, 2024 at 05:57PM Ongoing | Infectious Disease Accelerated Approvals Vaccines

Biologic Accelerated Approvals Based on a Surrogate Endpoint

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August 22, 2024 at 11:06PM SPIKEVAX

COVID19 Vaccine, mRNA

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August 22, 2024 at 07:23PM OTP Meetings for Approved Products

Information about OTP Meetings for Approved Products

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August 22, 2024 at 07:21PM Interactions with Office of Therapeutic Products

Information regarding Interactions with Office of Therapeutic Products

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August 22, 2024 at 02:50PM FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

This guidance establishes procedures for submitting, reviewing and responding to 513(g) requests for information regarding the classification and the regulatory requirements that may be applicable to a particular device.

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August 22, 2024 at 02:50PM Electronic Submission Template for Medical Device De Novo Requests

This final guidance provides submitters of De Novo requests to CDRH and CBER the associated content to support De Novo electronic submissions to FDA.


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August 20, 2024 at 08:17PM Compliance Actions (Biologics)

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

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August 20, 2024 at 08:00PM FDA Roundup: August 20, 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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August 20, 2024 at 02:01PM Vaccines and Related Biological Products Advisory Committee September 20, 2024 Meeting Announcement - 09/20/2024

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) September 20, 2024 Meeting announcement and meeting materials.

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August 19, 2024 at 10:49PM Administrative Guidances

This page lists Administrative Guidance documents.

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August 19, 2024 at 08:43PM Licensed Biological Products with Supporting Documents

Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

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August 19, 2024 at 06:16PM 2024 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the 2024 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).

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Sweden confirms first case of mpox strain outside Africa - Al Jazeera English

1. Sweden confirms first case of mpox strain outside Africa  Al Jazeera English
2. Sweden confirms first case of mpox strain circulating in Africa  NBC News
3. What is mpox, and why is this outbreak so concerning?  CNN
4. A new global health emergency: What is mpox, where are the outbreaks and will the virus spread?  The Associated Press
5. Sweden reports first case of highly-infectious mpox virus outside Africa amid outbreak there  Fox News

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Sweden confirms first case of mpox strain outside Africa - Al Jazeera English

1. Sweden confirms first case of mpox strain outside Africa  Al Jazeera English
2. What is mpox, and why is this outbreak so concerning?  CNN
3. Sweden confirms first case of mpox strain circulating in Africa  NBC News
4. A new global health emergency: What is mpox, where are the outbreaks and will the virus spread?  The Associated Press
5. Sweden reports first case of highly-infectious mpox virus outside Africa amid outbreak there  Fox News

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Recalled cucumbers linked to at least 449 illnesses have been pulled from stores, CDC says - NBC News

1. Recalled cucumbers linked to at least 449 illnesses have been pulled from stores, CDC says  NBC News
2. Cucumbers linked to salmonella outbreak in 31 states  ABC News
3. Recalled cucumbers in salmonella outbreak sickened 449 people in 31 states, CDC reports  USA TODAY
4. FDA, CDC trace cause of 31-state salmonella outbreak to cucumbers  WFTV Orlando
5. Recalled cucumbers in salmonella outbreak behind 449 illnesses, CDC says  CBS News

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Sweden reports first case of new monkeypox strain outside Africa - FRANCE 24 English

1. Sweden reports first case of new monkeypox strain outside Africa  FRANCE 24 English
2. Sweden confirms first case of mpox strain circulating in Africa  NBC News
3. As mpox continues to cross borders, is the US prepared for an outbreak?  USA TODAY
4. A new global health emergency: What is mpox, where are the outbreaks and will the virus spread?  The Associated Press
5. Mpox Vaccine Maker Ready To Produce 10 Million Doses  Barron's

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August 15, 2024 at 05:09PM Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement - 12/10/2020

This is the CBER Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement.

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WHO declares monkeypox a global public health emergency - FRANCE 24 English

1. WHO declares monkeypox a global public health emergency  FRANCE 24 English
2. WHO declares mpox outbreak a global health emergency  CNN
3. A new global health emergency: What is mpox, where are the outbreaks and what is the WHO doing?  The Associated Press
4. W.H.O. Declares Global Emergency Over New Mpox Outbreak  The New York Times
5. WHO invites mpox vaccine manufacturers to submit dossiers for emergency evaluation  World Health Organization (WHO)

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WHO declares monkeypox a global public health emergency - FRANCE 24 English

1. WHO declares monkeypox a global public health emergency  FRANCE 24 English
2. WHO declares mpox outbreak a global health emergency  CNN
3. A new global health emergency: What is mpox, where are the outbreaks and what is the WHO doing?  The Associated Press
4. World Health Organization Calls Mpox a Global Health Emergency  Bloomberg
5. WHO declares mpox a global health emergency as African outbreak grows  The Washington Post

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WHO declares monkeypox a global public health emergency - FRANCE 24 English

1. WHO declares monkeypox a global public health emergency  FRANCE 24 English
2. WHO declares mpox outbreak a global health emergency  CNN
3. A new global health emergency: What is mpox, where are the outbreaks and what is the WHO doing?  The Associated Press
4. World Health Organization Calls Mpox a Global Health Emergency  Bloomberg
5. WHO declares mpox a global health emergency as African outbreak grows  The Washington Post

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WHO declares mpox outbreaks in Africa a global health emergency as a new form of the virus spreads - The Associated Press

1. WHO declares mpox outbreaks in Africa a global health emergency as a new form of the virus spreads  The Associated Press
2. WHO declares mpox outbreak a global health emergency  CNN
3. WHO declares mpox a global health emergency as African outbreak grows  The Washington Post
4. WHO declares mpox a public health emergency as new strain spreads in Africa  ABC News
5. W.H.O. Declares Global Emergency Over New Mpox Outbreak  The New York Times

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August 14, 2024 at 04:58PM Consumer Updates

Science-based health and safety information you can trust.

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August 14, 2024 at 12:24PM Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

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August 13, 2024 at 11:16PM FDA Roundup: August 13, 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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August 13, 2024 at 08:43PM Consumers (Biologics)

Resources for consumers on biological products.

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August 13, 2024 at 04:24PM Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 5, 2024, to discuss and make recommendations on the selection of the 2024-2025 Formula for COVID-19 vaccines for use in the United States beginning in the fall of 2024.



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August 13, 2024 at 03:20PM Konrad Rejdak, M.D., Ph.D. - 671405 - 05/29/2024

Bioresearch Monitoring Program/IRB  

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August 12, 2024 at 04:16PM eSubmitter Application History

History of all updates to the application software in reverse chronological order by version number

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August 12, 2024 at 03:36PM 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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August 10, 2024 at 02:54AM Coronavirus (COVID-19) Update: June 8, 2021

Coronavirus (COVID-19) Update: June 8, 2021

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August 10, 2024 at 02:53AM Coronavirus (COVID-19) Update: May 25, 2021

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

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August 09, 2024 at 08:26PM 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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Boar's Head listeria outbreak: Another death, 10 more hospitalized, CDC says - Fox Business

1. Boar's Head listeria outbreak: Another death, 10 more hospitalized, CDC says  Fox Business
2. Deli Meat Recall as New Death, Hospitalizations Reported  Newsweek
3. More Cases and Additional Death Reported in Listeria Outbreak Linked to Meats Sliced at Delis  CDC
4. 3rd person dies in listeria outbreak linked to deli meat, more than 40 hospitalized across U.S.  Yahoo! Voices

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Boar's Head listeria outbreak: Another death, 10 more hospitalized, CDC says - Fox Business

1. Boar's Head listeria outbreak: Another death, 10 more hospitalized, CDC says  Fox Business
2. Deaths of 3 people now linked to listeria outbreak in Boar’s Head deli meat  MLive.com
3. Deli Meat Recall as New Death, Hospitalizations Reported  Newsweek
4. A 3rd person has died in connection to the listeria outbreak in Boar's Head products  NPR
5. Third person dies in listeria outbreak tied to deli meats: CDC  WABC-TV

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Listeria outbreak from Boar's Head deli meat leads to 10 new hospitalizations, 1 new death, CDC says - Newsday

1. Listeria outbreak from Boar's Head deli meat leads to 10 new hospitalizations, 1 new death, CDC says  Newsday
2. A 3rd person has died in connection to the listeria outbreak in Boar's Head products  NPR
3. Deaths of 3 people now linked to listeria outbreak in Boar’s Head deli meat  MLive.com
4. 3rd person dies in listeria outbreak linked to deli meat, more than 40 hospitalized across U.S.  Yahoo! Voices
5. Deli Meat Recall as New Death, Hospitalizations Reported  Newsweek

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Third person dies in listeria outbreak linked to Boar’s Head deli meats - The Guardian US

1. Third person dies in listeria outbreak linked to Boar’s Head deli meats  The Guardian US
2. Third Death Is Tied to Listeria, Health Officials Say  The New York Times
3. Third person dies, nine more fall ill in Boar’s Head deli meat listeria outbreak: CDC  New York Post
4. 3rd person dies in listeria outbreak linked to deli meat, more than 40 hospitalized across U.S.  NBC News
5. Virginia death linked to listeria outbreak from deli meat  NBC Washington

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August 08, 2024 at 07:09PM 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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August 07, 2024 at 08:08PM Respiratory Syncytial Virus (RSV)

There are FDA-approved vaccines, preventive treatments, and treatments for RSV now available. Check with your health care provider to see if you or your child are eligible.

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August 07, 2024 at 05:49PM CBER Reports

This page contains a summary of regulatory, research, and administrative accomplishments for the last 2 fiscal years and related reports.

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August 07, 2024 at 01:18AM CBER 2024 Orphan Approvals (new BLAs)

CBER 2024 Orphan Approvals

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August 06, 2024 at 11:07PM COVID-19, Flu and RSV

COVID, Flu and RSV vaccines, tests, and treatments - information about FDA-approved and authorized medical products for seasonal respiratory illnesses

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August 06, 2024 at 09:39PM OTP Meetings Glossary

List of OTP meeting terms and definitions

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August 06, 2024 at 07:49PM FDA Roundup: August 6, 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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August 06, 2024 at 05:41PM OTP Interact Meetings

Information about OTP Interact Meetings

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August 06, 2024 at 04:17PM OTP Requests for Clarification

Information about OTP Requests for Clarification

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August 05, 2024 at 03:48PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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Boar's Head recall: Woman files class action lawsuit against deli company - Fox Business

1. Boar's Head recall: Woman files class action lawsuit against deli company  Fox Business
2. Map shows 13 states with listeria cases linked to Boar's Head recall  USA TODAY
3. Here's what to know about recalled Boar's Head deli meats linked to a deadly listeria outbreak  The Associated Press
4. Metcalfe's Market closes deli counter due to multi-state listeria outbreak  Milwaukee Journal Sentinel
5. Deadly listeria outbreak prompts deli meat recall: What to know in the Bay Area  San Francisco Chronicle

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August 02, 2024 at 06:01PM Licensed Biological Products with Supporting Documents

Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

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August 02, 2024 at 03:50PM Advancing Clinical Trial Participation for the LGBTQIA+ Community

Representatives of the FDA were fortunate to attend a community discussion on advancing clinical trial diversity for sexual and gender minority communities to help improve the generalizability of trial results across the entire population of patients who may use medical products.

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August 02, 2024 at 02:58PM FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma

FDA approves Tecelra, a gene therapy to treat adults with unresectable or metastatic synovial sarcoma. Tecelra is also the first FDA-approved T cell receptor (TCR) gene therapy.

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August 02, 2024 at 02:42PM OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs - 09/05/2024

The focus of this virtual town hall is to answer questions related to CMC data and information needed to support late-stage INDs for cell therapy and tissue-engineered products.

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August 01, 2024 at 04:27PM Section 8400: Marketing Applications

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

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August 01, 2024 at 04:16PM FIBRYGA

For the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

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