Saturday, November 30, 2024

Friday, November 29, 2024

Recalled cucumbers linked to multistate salmonella outbreak, health agencies warn - CNN

  1. Recalled cucumbers linked to multistate salmonella outbreak, health agencies warn  CNN
  2. What To Know About The Big Salmonella Recall: Cucumbers and Costco Eggs Targeted (Updated)  Forbes
  3. Cucumbers recalled due to salmonella; 18 people infected have been hospitalized  CBS News
  4. Sunfed Produce, LLC Recalls Whole Fresh American Cucumbers Because of Possible Health Risks Due to Salmonella  FDA.gov
  5. Arizona-based produce company recalls cucumbers for possible Salmonella contamination  Arizona's Family


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Recalled cucumbers linked to multistate salmonella outbreak, health agencies warn - CNN

  1. Recalled cucumbers linked to multistate salmonella outbreak, health agencies warn  CNN
  2. Sunfed Produce, LLC Recalls Whole Fresh American Cucumbers Because of Possible Health Risks Due to Salmonella  FDA.gov
  3. Carrots, cucumbers and eggs; latest on e.coli, salmonella recalls  NorthJersey.com
  4. What To Know About The Big Salmonella Recall: Cucumbers and Costco Eggs Targeted (Updated)  Forbes
  5. Cucumber recall: Feds investigating salmonella outbreak; recalled items sent to over half of states  USA TODAY


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Thursday, November 28, 2024

Thanksgiving weather: Cold blast to follow rainy holiday - ABC News

  1. Thanksgiving weather: Cold blast to follow rainy holiday  ABC News
  2. Thanksgiving Day storm batters Northeast with rain and snow, delaying travel  NBC News
  3. Weather May Lead To Thanksgiving Travel Troubles  The Weather Channel
  4. Thanksgiving weather forecast: 'Arctic outbreak' and snow storms complicate holiday travel  Yahoo! Voices
  5. Snow, Winter Weather Warnings take effect tonight  WJW FOX 8 News Cleveland


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Snow and Rain Disrupt Holiday Travel as Storm Moves Across the Northeast - The New York Times

  1. Snow and Rain Disrupt Holiday Travel as Storm Moves Across the Northeast  The New York Times
  2. Thanksgiving storm arrives in New Hampshire with snow, heavy rain  WMUR Manchester
  3. Weather May Lead To Thanksgiving Travel Troubles  The Weather Channel
  4. Thanksgiving weather forecast: 'Arctic outbreak' and snow storms complicate holiday travel  Yahoo! Voices
  5. New York, Boston, Philadelphia, Baltimore, Denver, and More Face Thanksgiving Travel Disruption Amid Snowstorms, Rain, and Severe Weather Across the US: New Updates You Need to Know  Travel And Tour World


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Wednesday, November 27, 2024

November 27, 2024 at 05:30PM FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel)

FDA is investigating the known risk of hematologic malignancies with serious outcomes following Skysona, including those such as hospitalization, the requirement for allogeneic hematopoietic stem cell transplantation, and death - and is evaluating the need for further regulatory action.

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November 27, 2024 at 03:08PM CBER 2024 Orphan Approvals (new BLAs)

CBER 2024 Orphan Approvals

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Tuesday, November 26, 2024

November 26, 2024 at 02:59PM Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products

This guidance provides recommendations to sponsors regarding measurement of ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant cancer clinical trials that enroll premenopausal adults

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Monday, November 25, 2024

November 25, 2024 at 09:22PM 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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November 25, 2024 at 04:41PM Patient Listening Session Summaries

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

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Listeria outbreak tied to ready-to-eat meat leaves infant dead and 10 people sick - Scripps News

  1. Listeria outbreak tied to ready-to-eat meat leaves infant dead and 10 people sick  Scripps News
  2. Child dead, 11 people infected by listeria linked to ready-to-eat meat brand  The Washington Post
  3. Listeria outbreak: Recall issued as US says infant died  BBC.com
  4. 72,000 pounds of ready-to-eat meat, poultry recalled amid deadly listeria outbreak  CNN
  5. South Carolina: Deadly listeria outbreak tied to Upstate business  WYFF4 Greenville


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Saturday, November 23, 2024

Listeria outbreak: Recall issued as US says infant died - BBC.com

  1. Listeria outbreak: Recall issued as US says infant died  BBC.com
  2. Infant dies, 10 sickened amid listeria outbreak tied to ready-to-eat meat  Yahoo! Voices
  3. Ready-to-eat meat, poultry recalled over listeria risk; 11 infections, 1 death  USA TODAY
  4. 72,000 pounds of ready-to-eat meat, poultry recalled amid deadly listeria outbreak  CNN
  5. Infant dies after listeria outbreak linked to Spartanburg business, officials say  Fox Carolina


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Listeria outbreak: Recall issued as US says infant died - BBC.com

  1. Listeria outbreak: Recall issued as US says infant died  BBC.com
  2. Infant dies, 10 sickened amid listeria outbreak tied to ready-to-eat meat  Yahoo! Voices
  3. Listeria Outbreak Kills One, Prompts Recall for Yu Shang Food  The New York Times
  4. Nine people hospitalized in listeria outbreak linked to South Carolina food processor  The Guardian US
  5. Listeria outbreak with ties to Spartanburg business leaves infant dead, officials say  WYFF4 Greenville


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Listeria outbreak: Recall issued as US says infant died - BBC.com

  1. Listeria outbreak: Recall issued as US says infant died  BBC.com
  2. Infant dies, 10 sickened amid listeria outbreak tied to ready-to-eat meat  Yahoo! Voices
  3. 72,000 pounds of ready-to-eat meat, poultry recalled amid deadly listeria outbreak  CNN
  4. Infant dies and 10 others sick in latest listeria outbreak tied to ready-to-eat meat  NPR
  5. Nine people hospitalized in listeria outbreak linked to South Carolina food processor  The Guardian US


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Listeria outbreak: Recall issued as US says infant died - BBC.com

  1. Listeria outbreak: Recall issued as US says infant died  BBC.com
  2. Infant dies, 10 sickened amid listeria outbreak tied to ready-to-eat meat  Yahoo! Voices
  3. Infant dies and 10 others sick in latest listeria outbreak tied to ready-to-eat meat  NPR
  4. 72,000 pounds of ready-to-eat meat, poultry recalled amid deadly listeria outbreak  CNN
  5. Nine people hospitalized in listeria outbreak linked to South Carolina food processor  The Guardian US


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Listeria Outbreak Kills One, Prompts Recall for Yu Shang Food - The New York Times

  1. Listeria Outbreak Kills One, Prompts Recall for Yu Shang Food  The New York Times
  2. Infant dies, 10 sickened amid listeria outbreak tied to ready-to-eat meat  NBC News
  3. 72,000 pounds of ready-to-eat meat, poultry recalled amid deadly listeria outbreak  CNN
  4. Listeria outbreak with ties to Spartanburg establishment leaves infant dead, officials say  WYFF4 Greenville
  5. Infant dead in listeria outbreak tied to Yu Shang Food ready-to-eat meat and poultry products: CDC  ABC News


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Infant dead in listeria outbreak tied to Yu Shang Food ready-to-eat meat and poultry products: CDC - ABC News

  1. Infant dead in listeria outbreak tied to Yu Shang Food ready-to-eat meat and poultry products: CDC  ABC News
  2. Listeria Outbreak Kills One, Prompts Recall for Yu Shang Food  The New York Times
  3. 1 infant dies in California, 9 hospitalized across 4 states in latest listeria outbreak in ready-to-eat-meat, poultry  CBS News
  4. 72,000 pounds of ready-to-eat meat, poultry recalled amid deadly listeria outbreak  CNN
  5. Listeria outbreak with ties to Spartanburg establishment leaves infant dead, officials say  WYFF4 Greenville


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Friday, November 22, 2024

California infant dies from listeria amid outbreak tied to ready-to-eat meat products - Los Angeles Times

  1. California infant dies from listeria amid outbreak tied to ready-to-eat meat products  Los Angeles Times
  2. 72,000 pounds of ready-to-eat meat, poultry recalled amid deadly listeria outbreak  CNN
  3. 1 infant dies in California, 9 hospitalized across 4 states in latest listeria outbreak in ready-to-eat-meat, poultry  CBS News
  4. Listeria Outbreak Kills One, Prompts Recall for Yu Shang Food  The New York Times
  5. Infant dies, 10 sickened amid listeria outbreak tied to ready-to-eat meat  NBC News


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72,000 pounds of ready-to-eat meat, poultry recalled amid deadly listeria outbreak - CNN

  1. 72,000 pounds of ready-to-eat meat, poultry recalled amid deadly listeria outbreak  CNN
  2. Infant dies, 10 sickened amid listeria outbreak tied to ready-to-eat meat  NBC News
  3. Listeria outbreak tied to Yu Shang Food leaves California infant dead and 10 people sick  The Associated Press
  4. Listeria outbreak with ties to SC establishment leaves infant dead, officials say  WYFF4 Greenville
  5. Pregnant California woman loses twins after Listeria outbreak linked to recalled meat  San Francisco Chronicle


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November 22, 2024 at 08:49PM FDA Roundup: November 22, 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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November 22, 2024 at 03:19PM 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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Thursday, November 21, 2024

There's a Nationwide E. Coli Outbreak Linked to Ground Beef—Over 160,000 Pounds of Meat Recalled - EatingWell

  1. There's a Nationwide E. Coli Outbreak Linked to Ground Beef—Over 160,000 Pounds of Meat Recalled  EatingWell
  2. Over 83 tons of ground beef recalled nationwide, illnesses reported: USDA  WKBN.com
  3. Wolverine Packing Co. recalls more than 160,000 pounds of ground beef due to E. coli threat  Detroit News
  4. 167K+ pounds of ground beef packed in Detroit recalled due to possible E. coli contamination  FOX 2 Detroit
  5. Over 160,000 pounds of ground beef recalled due to E. coli risk  NBC News


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November 21, 2024 at 09:46PM About the FDA and How You Can Get Involved

About the FDA and How You Can Get Involved

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November 21, 2024 at 08:53PM FDA Patient Engagement Partnerships

FDA Patient Engagement Partnerships

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November 21, 2024 at 07:37PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Therapeutic Products (OTP).

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November 21, 2024 at 03:04PM Upholding Public Trust: FDA Office of Criminal Investigations’ Crucial Role in Bringing Drug Criminals to Justice

For more than 30 years, OCI investigators have been conducting and coordinating criminal investigations of suspected illegal activities involving FDA-regulated products, arresting bad actors, and referring cases to the Department of Justice for prosecution.

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Wednesday, November 20, 2024

November 20, 2024 at 03:58PM Administrative Guidances

This page lists Administrative Guidance documents.

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Monday, November 18, 2024

Carrots grown at California farm linked to national E. coli outbreak - SFGATE

  1. Carrots grown at California farm linked to national E. coli outbreak  SFGATE
  2. FDA Investigating Deadly E. Coli Outbreak Linked to Carrots Sold at Aldi, Trader Joe’s, Walmart, and More  Allrecipes
  3. Carrot recall: One person dead in Los Angeles County after E. coli outbreak linked to organic produce  ABC7 Los Angeles
  4. Carrots Sold at Costco, Walmart and More Recalled Nationwide Due to E. Coli Outbreak  EatingWell
  5. Carrot E. coli outbreak brings new concerns for shoppers in Colorado  CBS Colardo


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Carrots Recalled Nationwide at Trader Joe's, Whole Foods, and More Due to Possible E. Coli Contamination - Real Simple

  1. Carrots Recalled Nationwide at Trader Joe's, Whole Foods, and More Due to Possible E. Coli Contamination  Real Simple
  2. FDA Investigating Deadly E. Coli Outbreak Linked to Carrots Sold at Aldi, Trader Joe’s, Walmart, and More  Allrecipes
  3. Carrot recall: One person dead in Los Angeles County after E. coli outbreak linked to organic produce  ABC7 Los Angeles
  4. Carrots Sold at Costco, Walmart and More Recalled Nationwide Due to E. Coli Outbreak  EatingWell
  5. One person dies, dozens sickened after eating carrots contaminated with E. coli  PBS NewsHour


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Sunday, November 17, 2024

E. coli outbreak linked to organic carrots sickens people in 18 states - NPR

  1. E. coli outbreak linked to organic carrots sickens people in 18 states  NPR
  2. Carrot recall announced in connection to E. coli outbreak: See list of affected products  USA TODAY
  3. Carrots sold at Trader Joe's and Wegmans recalled due to possible E. coli contamination  NBC News
  4. Outbreak Investigation of E. coli O121:H9: Organic Carrots (November 2024)  FDA.gov
  5. Where People Got Sick: E. coli Outbreak, Organic Carrots, November 2024  CDC


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E. coli outbreak linked to organic carrots leaves 1 dead and dozens sickened across the US - CNN

  1. E. coli outbreak linked to organic carrots leaves 1 dead and dozens sickened across the US  CNN
  2. Recall issued on organic whole and baby carrots linked to E. coli cases  The Arizona Republic
  3. Carrot recall announced in connection to E. coli outbreak: See list of affected products  USA TODAY
  4. Outbreak Investigation of E. coli O121:H9: Organic Carrots (November 2024)  FDA.gov
  5. Where People Got Sick: E. coli Outbreak, Organic Carrots, November 2024  CDC


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E. coli outbreak linked to organic carrots leaves 1 dead and dozens sickened across the US - CNN

  1. E. coli outbreak linked to organic carrots leaves 1 dead and dozens sickened across the US  CNN
  2. E. coli outbreak linked to organic carrots sickens people in 18 states  NPR
  3. Carrot recall announced in connection to E. coli outbreak: See list of affected products  USA TODAY
  4. Carrots sold at Trader Joe's and Wegmans recalled due to possible E. coli contamination  NBC News
  5. Outbreak Investigation of E. coli O121:H9: Organic Carrots (November 2024)  FDA.gov


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E. coli outbreak linked to organic carrots leaves 1 dead and dozens sickened across the US - Yahoo! Voices

  1. E. coli outbreak linked to organic carrots leaves 1 dead and dozens sickened across the US  Yahoo! Voices
  2. 1 Dead and Dozens Ill in E. Coli Outbreak Linked to Organic Carrots  The New York Times
  3. E. coli outbreak linked to organic carrots leaves 1 dead, 15 hospitalized  ABC News
  4. Carrot recall announced in connection to E. coli outbreak: See list of affected products  USA TODAY
  5. Organic carrots recalled after E. coli outbreak. These are the brands and grocery stores impacted.  CBS News


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E. Coli Outbreak Linked to Organic Carrots - The New York Times

  1. E. Coli Outbreak Linked to Organic Carrots  The New York Times
  2. E. coli outbreak linked to organic carrots leaves 1 dead and dozens sickened across the US  CNN
  3. 1 death reported in E. coli outbreak linked to carrots old by Grimmway Farms; 39 cases across country, CDC says  ABC7 New York
  4. Carrot recall announced in connection to E. coli outbreak: See list of affected products  USA TODAY
  5. Carrots sold at Trader Joe's and Wegmans recalled due to possible E. coli contamination  NBC News


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Saturday, November 16, 2024

McDonald’s is investing $100 million to bring customers back after E. coli outbreak - KTLA Los Angeles

  1. McDonald’s is investing $100 million to bring customers back after E. coli outbreak  KTLA Los Angeles
  2. McDonald’s spends $100 million to lure customers back after E. coli outbreak  CNN
  3. McDonald's investing $100 million to lure customers back to the fast food giant after E. coli outbreak  CBS News
  4. McDonald's to invest more than $100 million to speed up recovery after E. coli outbreak  CNBC
  5. More illnesses reported in E. coli outbreak tied to onions on McDonald's Quarter Pounders  USA TODAY


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McDonald’s is investing $100 million to bring customers back after E. coli outbreak - The Associated Press

McDonald’s is investing $100 million to bring customers back after E. coli outbreak  The Associated PressView Full Coverage on Google News

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Washington’s lobbyists are stunned Trump chose RFK Jr. - POLITICO

  1. Washington’s lobbyists are stunned Trump chose RFK Jr.  POLITICO
  2. Opinion | How Robert F. Kennedy Jr. Could Destroy One of Civilization’s Best Achievements  The New York Times
  3. Breaking Down RFK Jr.’s Vaccine Doublespeak  Rolling Stone
  4. Global health experts sound alarm over RFK Jr., citing Samoa outbreak  The Washington Post
  5. Trump’s Cabinet: Pence Speaks Against RFK Jr Nomination To HHS  Forbes


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Health stocks hit after Trump taps RFK Jr for top regulator post - BBC.com

  1. Health stocks hit after Trump taps RFK Jr for top regulator post  BBC.com
  2. Global health experts sound alarm over RFK Jr., citing Samoa outbreak  The Washington Post
  3. Opinion | Robert F. Kennedy Jr. Could Do Almost Limitless Harm  The New York Times
  4. Trump’s Cabinet: Pence Speaks Against RFK Jr Nomination To HHS  Forbes
  5. Pence says he opposes RFK Jr.’s nomination for HHS secretary because of his stance on abortion  Fox News


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Thursday, November 14, 2024

November 14, 2024 at 10:25PM CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices

Document issued on October 3, 2006 and supersedes Compliance Policy Guide (CPG) “Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16)” that was issued in March 1995.

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November 14, 2024 at 04:06PM Approved Blood Products

Products that are regulated as Biologics License Applications (BLAs), New Drug Applications (NDAS), Premarket Approvals (PMAs), and 510(k)s.

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November 14, 2024 at 02:49PM FDA Approves First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency

FDA Approves Kebilidi, an adeno-associated virus vector-based gene therapy indicated for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

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Wednesday, November 13, 2024

November 13, 2024 at 09:22PM WILATE

In adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and for on-demand treatment and control of bleeding episodes.

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November 13, 2024 at 08:03PM eSubmitter Application History

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

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November 13, 2024 at 03:31PM About the FDA and How You Can Get Involved

About the FDA and How You Can Get Involved

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Tuesday, November 12, 2024

November 12, 2024 at 09:21PM Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers

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

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November 12, 2024 at 08:19PM Resources Related to Regenerative Medicine Therapies

Information on FDA’s Framework for the Regulation of Regenerative Medicine Products


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Friday, November 8, 2024

November 04, 2024 at 02:26PM Moderna COVID-19 Vaccine

Information about Moderna COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccines are now FDA-authorized for all doses for individuals ages 6 months and older.

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November 08, 2024 at 10:36PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Therapeutic Products (OTP).

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November 08, 2024 at 09:05PM FDA Roundup: November 8, 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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November 08, 2024 at 03:27PM Expanded Access to Experimental Biologics

Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtai

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Thursday, November 7, 2024

November 07, 2024 at 03:08PM Influenza Virus Vaccine, Trivalent, Types A and B

List of Influenza Virus Vaccine, Trivalent, Types A and B products

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November 07, 2024 at 03:04PM Influenza Virus Vaccine, H5N1 (for National Stockpile)

For active immunization of persons 18 through 64 years of age at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.

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November 07, 2024 at 12:05PM Hepatitis B Vaccine (Recombinant)

List of Hepatitis B Vaccine (Recombinant)products

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November 07, 2024 at 12:02PM Hepatitis A Vaccine, Inactivated

List of Hepatitis A Vaccine, Inactivated products

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Wednesday, November 6, 2024

November 06, 2024 at 04:37PM Select CBER Projects and Activities

CBER projects and activities that address the 21st Century Cures Act and the Prescription Drug User Fees Act VI Reauthorization (PDUFA VI) as authorized by the FDA Reauthorization Act (FDARA)

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November 06, 2024 at 04:23PM CBER-Regulated Products: Shortages and Discontinuations

A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand.

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November 06, 2024 at 02:00PM Cellular, Tissue, and Gene Therapies Advisory Committee November 21, 2024 Meeting Announcement - 11/21/2024

This is the main page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) November 21, 2024 announcement and meeting materials.

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Tuesday, November 5, 2024

November 05, 2024 at 11:29PM FDA Roundup: November 5, 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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November 05, 2024 at 08:26PM Vaccine Adverse Event Reporting System (VAERS) Questions and Answers

VAERS is a national vaccine safety surveillance program created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 (NCVIA) and is administered by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC).

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November 05, 2024 at 03:43PM FDA develops rapid and sensitive assay to assess antibody response to Ebola virus vaccine without using the virus

FDA develops rapid and sensitive assay to assess antibody response to Ebola virus vaccine without using the virus

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November 05, 2024 at 03:00PM One Health - Optimal Public Health Outcomes for Humans and Animals in Our Shared Environment

FDA collaborates with stakeholders across disciplines and sectors to promote the health of humans, animals, and the environment using science, technology, and innovation.

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November 05, 2024 at 02:44PM High-dose influenza vaccine appears better than standard-dose vaccines in preventing deaths from A(H3N2) influenza among older adults

High-dose influenza vaccine was more effective at preventing post-influenza deaths among elderly individuals during the 2012-2013 influenza season than standard-dose vaccines-- when the A(H3N2) influenza viruses were broadly circulating-- according to a study done by researchers at the U.S. Food and

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Monday, November 4, 2024

November 04, 2024 at 05:31PM Testing Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases

Testing HCT/P Donors for Relevant Communicable Diseases

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November 04, 2024 at 02:33PM Novavax COVID-19 Vaccine, Adjuvanted

Novavax COVID-19 Vaccine, Adjuvanted

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November 04, 2024 at 02:26PM Moderna COVID-19 Vaccine

Information about Moderna COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccines are now FDA-authorized for all doses for individuals ages 6 months and older.

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Friday, November 1, 2024

November 01, 2024 at 07:34PM 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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November 01, 2024 at 05:56PM 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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November 01, 2024 at 01:55PM FDA Rare Disease Innovation Hub

FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.

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November 01, 2024 at 01:50PM FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub

The Hub will act as the single point of engagement and connection with outside parties for drug and biological product development and represents a dynamic new model for cross-center collaboration at the agency.

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