December 29, 2023 at 08:05PM Roster of the Allergenic Products Advisory Committee

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

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December 28, 2023 at 03:04PM Potency Assurance for Cellular and Gene Therapy Products

This is the Draft Guidance for Industry, Potency Assurance for Cellular and Gene Therapy Products

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Israel Gaza war: Israel warns Hezbollah and Lebanon over border fighting - BBC.com

1. Israel Gaza war: Israel warns Hezbollah and Lebanon over border fighting  BBC.com
2. Israel-Hamas War: Live Updates  The New York Times
3. Israel warns about Lebanon border hostilities: "The hourglass for a political settlement is running out"  CBS News
4. Israeli soldiers targeted in ‘extremely bloody and intense’ battles as Gaza Strip tensions rise  Fox News
5. Northern towns rocked by heaviest Hezbollah barrages since outbreak of war  The Times of Israel

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Northern Israel comes under ‘most intense’ attacks since war against Hamas broke out in October - Fox News

1. Northern Israel comes under ‘most intense’ attacks since war against Hamas broke out in October  Fox News
2. Northern towns rocked by heaviest Hezbollah barrages since outbreak of war  The Times of Israel
3. Australia checks Hezbollah claim of citizen killed in Israeli strike  Reuters
4. Hezbollah rocks northern Israel with most attacks in single day of war  The Jerusalem Post

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December 27, 2023 at 05:01PM Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence

Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research Real-World Evidence

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December 27, 2023 at 04:37PM YESCARTA (axicabtagene ciloleucel)

YESCARTA is a treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

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With Gaza's health system in tatters, a struggle to spot and prevent outbreaks : Goats and Soda - NPR

1. With Gaza's health system in tatters, a struggle to spot and prevent outbreaks : Goats and Soda  NPR
2. In Gaza, Doctors Without Borders coordinator witnesses children's extreme suffering  NPR
3. UN Agency Records 360000 Infectious Disease Cases in Gaza Shelters — 1 for Every 6 Palestinians in Region  Truthout
4. Surgeon describes experience treating patients in Gaza  PBS NewsHour
5. Only Gauze and Iodine for Injured Patients at Gaza Field Hospital  U.S. News & World Report

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December 21, 2023 at 10:20PM 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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December 22, 2023 at 01:53PM Clinical Guidances

This page lists Clinical Guidance documents.

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US Ready To "Support" UN Gaza Vote | IDF “Kills” 2,000 Hamas Fighters | “Israel Doomed To Fail” - CRUX

1. US Ready To "Support" UN Gaza Vote | IDF “Kills” 2,000 Hamas Fighters | “Israel Doomed To Fail”  CRUX
2. Israel has killed more than 2,000 ‘terrorists’ since the end of Gaza Strip cease-fire, IDF says  Fox News
3. Dec. 21: IDF says 2,000 Hamas gunmen killed this month, 8,000 since war outbreak  The Times of Israel
4. Israel Army Claims Killed 2,000 Gaza Operatives This Month  NDTV
5. Israel Has Killed Over 2000 Hamas Terrorists This Month, IDF Says  Algemeiner

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December 21, 2023 at 09:17PM HIBERIX

HIBERIX is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b.

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December 21, 2023 at 04:58PM Realizing the Promise of Real-World Evidence

Realizing the full potential of RWE in regulatory decision-making presents several challenges, and work is underway at the FDA to better understand this area.

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December 21, 2023 at 02:45PM Data Standards for Drug and Biological Product Submissions Containing Real-World Data

Data Standards for Drug and Biological Product Submissions Containing Real-World Data

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December 20, 2023 at 06:54PM Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Announcement - 09/22/2022

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Announcement.

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December 20, 2023 at 03:42PM Increasing Options in Clinical Research to Facilitate Medical Product Development

FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of people participating in clinical research.

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December 19, 2023 at 11:58PM Devices Guidances

This page lists Medical Device Guidance documents.

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December 19, 2023 at 10:55PM FDA Roundup: December 19, 2023

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

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December 18, 2023 at 03:24PM Know Your Treatment Options for COVID-19

Patients today have several treatment options to prevent hospitalization and other serious complications of COVID-19. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use.

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December 18, 2023 at 05:58PM 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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December 18, 2023 at 05:17PM FDA Patient Listening Sessions

Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives.

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December 15, 2023 at 09:13PM FDA Roundup: December 15, 2023

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

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December 15, 2023 at 07:23PM 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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December 15, 2023 at 06:36PM 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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Baby swept away in Tennessee tornado found alive 'by the grace of God' in unusual spot - New York Post

1. Baby swept away in Tennessee tornado found alive 'by the grace of God' in unusual spot  New York Post
2. 4-month-old found alive in downed tree after Tennessee tornado destroys home: "I was pretty sure he was dead"  CBS News
3. Tense moments caught on camera as Clarksville tenants told to get out  WKRN News 2
4. Middle Tennessee tornadoes left many pets homeless and lost  Tennessean
5. 2 roads remain closed after tornado outbreak in Davidson County  WSMV 4

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December 14, 2023 at 05:43PM Standards Development for Regenerative Medicine Therapies

Section 3036 of the 21st Century Cures Act refers to the development of standards for regenerative medicine therapies, including products designated regenerative medicine advanced therapies.

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December 14, 2023 at 05:37PM Vaccines and Related Biological Products Advisory Committee March 5, 2021 Meeting Announcement - 03/05/2021

This is the CBER Vaccines and Related Biological Products Advisory Committee March 5, 2021 Meeting Announcement.

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December 14, 2023 at 03:05PM 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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December 14, 2023 at 02:50PM 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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December 13, 2023 at 08:50PM Vaccines and Related Biological Products Advisory Committee June 10, 2021 Meeting Announcement - 06/10/2021

This is the CBER Vaccines and Related Biological Products Advisory Committee June 10, 2021 Meeting Announcement.

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December 13, 2023 at 06:48PM eSubmitter Application History

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

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December 12, 2023 at 08:01PM Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement - 09/17/2021

This is the CBER Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement.

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December 12, 2023 at 03:53PM Field Science - Laboratory Manual

The Laboratory Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used as an agency policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and cour

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December 11, 2023 at 08:35PM Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Announcement - 10/14/2021

This is the CBER Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Announcement.

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December 11, 2023 at 05:23PM BIVIGAM

Product approval information is indicated for treatment of Primary Immunodeficiency Diseases (PIDD)

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Tennessee tornado outbreak latest: Two tornadoes confirmed, ranked - Tennessean

1. Tennessee tornado outbreak latest: Two tornadoes confirmed, ranked  Tennessean
2. 6 dead, nearly 2 dozen injured after severe storms tear through central Tennessee  WHAS11
3. Cincinnati-area nonprofit to deploy disaster team to Tennessee  WHIO
4. 'I said it's time to go': Clarksville man recounts living through a tornado  News Channel 5 Nashville
5. Tennessee residents clean up after severe weekend storms killed 6 people and damaged neighborhoods  Yahoo News

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Nashville tornado: Residents clean up after severe weekend storms kill 6 - The Associated Press

1. Nashville tornado: Residents clean up after severe weekend storms kill 6  The Associated Press
2. 6 dead, nearly 2 dozen injured after severe storms tear through central Tennessee  WHAS11
3. Cincinnati-area nonprofit to deploy disaster team to Tennessee  WHIO
4. 'I said it's time to go': Clarksville man recounts living through a tornado  News Channel 5 Nashville
5. Tennessee Tornadoes: Drone shows devastation left behind by tornado outbreak  FOX NASHVILLE

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December 08, 2023 at 11:10PM Consumer Updates

Science-based health and safety information you can trust.

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December 08, 2023 at 06:49PM 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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December 08, 2023 at 05:10PM FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease

The FDA approved the first cell-based gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease in patients 12 years and older. One of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology.

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Deaths from tainted cantaloupe rise to 8 in U.S. and Canada - NBC News

1. Deaths from tainted cantaloupe rise to 8 in U.S. and Canada  NBC News
2. Third death in US, 5 deaths in Canada reported in salmonella outbreak linked to cantaloupe  CNN
3. CDC issues renewed warning of cantaloupe with salmonella  FOX31 Denver
4. Oregonian dies from cantaloupe-linked Salmonella outbreak  Fox 12 Oregon
5. More Wisconsin illnesses linked to cantaloupe, more deaths in US, Canada  WBAY

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December 07, 2023 at 08:02PM 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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December 07, 2023 at 03:59PM COMIRNATY

COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

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December 05, 2023 at 10:59PM FDA Roundup: December 5, 2023

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

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December 05, 2023 at 06:51PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under

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December 04, 2023 at 07:39PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Tissues and Advanced Therapies (OTAT).

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December 04, 2023 at 07:20PM Wilate

Product approval information is indicated for 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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December 04, 2023 at 06:53PM The Importance of Clinical Trial Transparency and FDA Oversight

The U.S. Food and Drug Administration monitors compliance with the ClinicalTrials.gov registration and results information submission requirements as a critical part of our mission to protect public health.

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December 01, 2023 at 10:46PM FDA Roundup: December 1, 2023

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

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December 01, 2023 at 10:05PM ODACTRA

Product approval information for use in adults 18 through 65 years of age as immunotherapy for house dust mite- (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust m

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December 01, 2023 at 09:56PM 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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Cantaloupe salmonella outbreak: Here's what pre-cut products to avoid - NPR

1. Cantaloupe salmonella outbreak: Here's what pre-cut products to avoid  NPR
2. More people sick in severe salmonella outbreak linked to cantaloupe  The Washington Post
3. Don't eat pre-cut cantaloupe if the source is unknown, CDC says, as deadly salmonella outbreak grows  Yahoo Finance
4. SYLVIAN CHARLEBOIS: We need to up our food recall game  Saltwire
5. Severe outbreak tied to cantaloupe sickens 117 in 34 states; half hospitalized  Ars Technica
6. View Full Coverage on Google News

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