November 30, 2023 at 03:57PM Blood Products Advisory Committee November 4, 2021 Meeting Announcement - 11/04/2021

This is the CBER Blood Products Advisory Committee November 4, 2021 Meeting Announcement.

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November 30, 2023 at 03:51PM 2021 Meeting Materials, Blood Products Advisory Committee

This is the main page for the CBER 2021 Meeting Materials, Blood Products Advisory Committee.

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November 30, 2023 at 03:44PM Allergenic Products Advisory Committee October 28, 2021 Meeting Announcement - 10/28/2021

This is the main page for the CBER Allergenic Products Advisory Committee October 28, 2021 Meeting Announcement.

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November 30, 2023 at 02:10PM Remarks by Commissioner Robert Califf to the National Consumer League Health Advisory Council Winter Meeting - 11/29/2023

Remarks by Robert M. Califf, M.D.
Commissioner of Food and Drugs
National Consumer League Health Advisory Council Winter Meeting
Nov. 29, 2023

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November 29, 2023 at 07:15PM Vaccines and Related Biological Products Advisory Committee October 2, 2020 Meeting Announcement - 10/02/2020

This is the CBER Vaccines and Related Biological Products Advisory Committee October 2, 2020 Meeting Announcement.

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November 29, 2023 at 06:29PM Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement - 10/22/2020

This is the CBER Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement.

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November 29, 2023 at 03:41PM Antimicrobial Resistance Information from FDA

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

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November 29, 2023 at 01:48AM BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication - FDA Investigating Serious Risk of T-cell Malignancy

The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.

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November 28, 2023 at 09:53PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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November 28, 2023 at 08:22PM BK231004- Blood Product Questionnaire Module

This is intended to support single and/or multi-site blood establishment collection facilities to create/manage/review donor history questionnaire/information, determine visit requirements, and determine donor eligibility through system logic or trained facility staff interpretation.

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November 28, 2023 at 05:24PM 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 28, 2023 at 04:43PM 5 Things to Know About Triclosan

Triclosan is an ingredient added to many consumer products to help reduce or prevent bacterial contamination. Are there benefits?

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November 27, 2023 at 09:54PM Tissue Guidances

This page contains a listing of tissue related guidances.

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Iowans sickened from cantaloupe contaminated with salmonella - KCCI Des Moines

1. Iowans sickened from cantaloupe contaminated with salmonella  KCCI Des Moines
2. Salmonella outbreak linked to cantaloupes has killed 2, infected 99: This is a 'wake-up call'  Fox News
3. Cantaloupe recall  4 News Now
4. Cantaloupes Linked to Deadly Salmonella Outbreak, U.S. Says  The New York Times
5. Cantaloupe recall expands, 3 sick in Georgia – WSB-TV Channel 2 - Atlanta  WSB Atlanta
6. View Full Coverage on Google News

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China ministry seeks more fever clinics to combat respiratory illness surge - CNBC

1. China ministry seeks more fever clinics to combat respiratory illness surge  CNBC
2. China's mysterious Pneumonia outbreak | WION  WION
3. Chinese officials say surge in respiratory illness likely not caused by novel pathogen  Fox News
4. Mycoplasma Likely Main Culprit Of Outbreak Of Pediatric Cases Of Pneumonia Worldwide  Forbes
5. China Says Multiple Pathogens Are Behind Spike in Respiratory Illnesses  Bloomberg
6. View Full Coverage on Google News

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China Says Multiple Pathogens Are Behind Spike in Respiratory Illnesses - Bloomberg

1. China Says Multiple Pathogens Are Behind Spike in Respiratory Illnesses  Bloomberg
2. China's mysterious Pneumonia outbreak | WION  WION
3. Chinese officials say surge in respiratory illness likely not caused by novel pathogen  Fox News
4. Mycoplasma Likely Main Culprit Of Outbreak Of Pediatric Cases Of Pneumonia Worldwide  Forbes
5. Fears allayed over spreading lung inflammation among children  Bangkok Post
6. View Full Coverage on Google News

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More salmonella cases, two deaths reported as cantaloupe recall expands - CNN

1. More salmonella cases, two deaths reported as cantaloupe recall expands  CNN
2. FDA expands cantaloupe recall after salmonella infections double in a week  The Associated Press
3. Salmonella-Fruit Recall Expands To 32 States: 2 Dead, 45 Hospitalized  Patch
4. 2 dead, dozens hospitalized in salmonella outbreak linked to cantaloupes in 32 states  KMVT
5. FDA expands cantaloupe recall after more reports of salmonella infections, 2 deaths  WKRC TV Cincinnati
6. View Full Coverage on Google News

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November 24, 2023 at 03:31PM 2020 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the CBER 2020 Meeting Materials, Vaccines and Related Biological Products Advisory Committee.

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November 24, 2023 at 01:47PM Section 8100: Communication

This is the CBER SOPP Section 8100: Communication main page.

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Mysterious Pneumonia Spreads in China: Cases Surge | Vantage with Palki Sharma - Firstpost

1. Mysterious Pneumonia Spreads in China: Cases Surge | Vantage with Palki Sharma  Firstpost
2. Mysterious respiratory outbreak in China gets attention of World Health Organization  New York Post
3. Beijing families line up at a hospital after an increase in respiratory illnesses among kids  NBC News
4. China's pneumonia scare: Transparency please | Mint  Mint
5. China pressed by World Health Organization after respiratory illness clusters reported  Fox News
6. View Full Coverage on Google News

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Undiagnosed Pneumonia outbreak in China, reports eerily similar to 2019 Covid outbreak | WION - WION

1. Undiagnosed Pneumonia outbreak in China, reports eerily similar to 2019 Covid outbreak | WION  WION
2. So many kids are falling sick in China that a children's hospital said it saw 13,000 cases in a single day  Business Insider India
3. WHO asks China for more information on spike in pediatric respiratory illnesses  CNN
4. China sees mysterious pneumonia outbreak, hospitals flooded with patients | WION  WION
5. Chinese Hospitals Have Been “overwhelmed With Sick Children” As An Outbreak Of Pneumonia – Greek City Times  GreekCityTimes.com
6. View Full Coverage on Google News

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WHO asks China for more details on unexplained pneumonia outbreak - Al Jazeera English

1. WHO asks China for more details on unexplained pneumonia outbreak  Al Jazeera English
2. China sees mysterious pneumonia outbreak, hospitals flooded with patients | WION  WION
3. W.H.O. Asks China for Details on Surge of Respiratory Illness in Children  The New York Times
4. Thousands of parents in China are watching their children fall ill as colds and pneumonia sweep its biggest ci  Business Insider India
5. WHO asks China to provide more clinical details on Pneumonia outbreak | In-Live discussion  WION
6. View Full Coverage on Google News

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WHO asks China for details on outbreaks of respiratory illness - Reuters

1. WHO asks China for details on outbreaks of respiratory illness  Reuters
2. China sees mysterious pneumonia outbreak, hospitals flooded with patients | WION  WION
3. WHO statement on reported clusters of respiratory illness in children in northern China  World Health Organization
4. WHO asks China for more information on spike in pediatric respiratory illnesses  CNN
5. WHO asks China for more details on unexplained pneumonia outbreak  Al Jazeera English

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November 22, 2023 at 06:28PM Cellular, Tissue, and Gene Therapies Advisory Committee March 10, 2022 Meeting Announcement - 03/10/2022

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

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November 22, 2023 at 02:45PM COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

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November 21, 2023 at 07:57PM Cellular, Tissue, and Gene Therapies Advisory Committee April 15, 2021 Meeting Announcement - 04/15/2021

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee April 15, 2021 Meeting Announcement.

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November 21, 2023 at 05:25PM Cellular, Tissue, and Gene Therapies Advisory Committee September 2-3, 2021 Meeting Announcement - 09/02/2021

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee September 2-3, 2021 Meeting Announcement.

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November 21, 2023 at 02:00PM Translation of Good Laboratory Practice Study Reports: Questions and Answers

This guidance provides information to sponsors and nonclinical laboratories regarding the 16 language translation of study reports for studies conducted in compliance with good laboratory 17 practice (GLP) regulations (21 CFR part 58).

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Nationwide recall of peaches, plums and nectarines linked to deadly listeria outbreak - CBS News

1. Nationwide recall of peaches, plums and nectarines linked to deadly listeria outbreak  CBS News
2. Fruit recalled after Listeria outbreak affects Ohio, other states  NBC4 Columbus
3. CDC warns of listeria outbreak in fruit after one person died and 10 are hospitalized across seven states  Daily Mail
4. Peaches, Nectarines, and Plums recalled For Deadly Listeria Outbreak  TODAY
5. HMC Farms recalls peaches, plums and nectarines  WPRI
6. View Full Coverage on Google News

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November 20, 2023 at 08:31PM Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

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November 20, 2023 at 08:21PM Biologics Electronic Reading Room (eFOIA)

The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.

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November 20, 2023 at 07:29PM 2021 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

This is the main page for the CBER 2021 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee.

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November 20, 2023 at 07:13PM Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement - 05/08/2020

This is the main page for the CBER Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement.

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Salmonella in cantaloupes sickens dozens in 15 states, U.S. health officials say - ABC News

1. Salmonella in cantaloupes sickens dozens in 15 states, U.S. health officials say  ABC News
2. Cantaloupe, fruit products recalled amid CDC investigation of salmonella infections  CNN
3. Outbreak of Salmonella linked to cantaloupes and pre-cut fruit products, 1 Virginian infected  WRIC ABC 8News
4. Salmonella outbreak linked to cantaloupes sickens more than 40 people and hospitalizes 17 in US  Daily Mail
5. Seven salmonella cases in Arizona linked to fruit part of outbreak in 14 other states  Arizona's Family
6. View Full Coverage on Google News

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Cantaloupe, fruit products recalled amid CDC investigation of salmonella infections - CNN

1. Cantaloupe, fruit products recalled amid CDC investigation of salmonella infections  CNN
2. Salmonella outbreak linked to cantaloupes sickens more than 40 people and hospitalizes 17 in US  Daily Mail
3. Outbreak of Salmonella linked to cantaloupes and pre-cut fruit products, 1 Virginian infected  WRIC ABC 8News
4. Multiple people in Nebraska were infected from cantaloupe contaminated with salmonella  KETV Omaha
5. Salmonella in cantaloupes sickens dozens in 15 states, U.S. health officials say  The Associated Press
6. View Full Coverage on Google News

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November 17, 2023 at 10:19PM FDA Roundup: November 17, 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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November 16, 2023 at 03:55PM FAQs: What happens to EUAs when a public health emergency ends?

Answers to frequently asked questions about what happens to Emergency Use Authorizations (EUAs), and medical products available under EUA, when a public health emergency ends.

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November 14, 2023 at 06:28PM Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act

Notifying FDA of a permanent discontinuance or interruption in manufacturing of certain devices as required by section 506J of the FD&C Act

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November 15, 2023 at 10:51PM Remarks by Commissioner Robert Califf to the Healthcare Distribution Alliance Board of Directors meeting - 11/15/2023

Speech by Robert M. Califf, M.D.
Healthcare Distributors Alliance
Bd of Directors meeting
November 15, 2023
Washington, DC

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November 15, 2023 at 08:52PM Pfizer-BioNTech COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Authorized For Individuals 6 Months through 11 Years of Age

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November 15, 2023 at 04:04PM CBER 2023 Orphan Approvals (new BLAs)

CBER Orphan Approvals for 2023

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November 14, 2023 at 11:43PM Remarks by Dr. Robert Califf on the Reagan Udall Foundation's report and recommendations on Evidence Generation - 11/14/2023

Remarks by Robert M. Califf, M.D.
Commissioner, US Food and Drugs
Reagan Udall Foundation Report on Evidence Generation
November 14, 2023
Silver Spring, MD


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November 14, 2023 at 09:24PM FDA Roundup: November 14, 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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November 14, 2023 at 08:48PM eSubmitter Application History

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

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November 14, 2023 at 02:14PM 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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November 14, 2023 at 12:42PM Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

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November 14, 2023 at 12:04AM Roster of the Blood Products Advisory Committee

This is the Roster of the Blood Products Advisory Committee (BPAC).

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November 13, 2023 at 03:58PM Webinar - Breakthrough Devices Program Updated Final Guidance - 11/14/2023

The FDA will host a webinar for industry and other interested stakeholders to discuss the updated final guidance for the Breakthrough Devices Program.

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These are the batches of pet food recalled after salmonella outbreak - AS USA

1. These are the batches of pet food recalled after salmonella outbreak  AS USA
2. Massive Dog and Cat Food Recall Has Been Issued Nationwide  Parade Magazine
3. Pet food recall grows: Babies sickened by salmonella in tainted kibble, officials say  The Hill
4. Salmonella outbreak reaches Oklahoma | News | fox23.com  KOKI FOX 23 TULSA
5. Mid America Pet Food expands recall beyond Victor brand dog foods  USA TODAY
6. View Full Coverage on Google News

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Pet food recall grows: Babies sickened by salmonella in tainted kibble, officials say - The Hill

1. Pet food recall grows: Babies sickened by salmonella in tainted kibble, officials say  The Hill
2. 6 infants sickened by salmonella outbreak linked to pet food, multiple brands recalled  Yahoo! Voices
3. Massive Dog and Cat Food Recall Has Been Issued Nationwide  Parade Magazine
4. Several infants sickened in salmonella outbreak linked to pet food  CBS Evening News
5. Salmonella outbreak reaches Oklahoma | News | fox23.com  KOKI FOX 23 TULSA
6. View Full Coverage on Google News

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Pet foods recalled after infants sickened by salmonella - The Hill

1. Pet foods recalled after infants sickened by salmonella  The Hill
2. 6 infants sickened by salmonella outbreak linked to pet food, multiple brands recalled  Yahoo! Voices
3. Massive Dog and Cat Food Recall Has Been Issued Nationwide  Parade Magazine
4. Babies are getting sick from exposure to salmonella in recalled pet food: FDA  New York Post
5. Salmonella outbreak reaches Oklahoma | News | fox23.com  KOKI FOX 23 TULSA
6. View Full Coverage on Google News

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November 09, 2023 at 09:56PM 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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November 09, 2023 at 04:38PM General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final Rules

List of General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final Rules

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November 09, 2023 at 12:38PM Antimicrobial Resistance Information from FDA

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

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November 08, 2023 at 04:58PM 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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November 08, 2023 at 04:15PM Study Data Technical Conformance Guide - Technical Specifications Document

This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.

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November 08, 2023 at 03:59PM BK230840- Elecsys Anti-CMV; PreciControl Anti-CMV; PreciControl Release Anti-CMV

Elecsys Anti-CMV is a double antigen sandwich immunoassay with streptavidin microparticles, biotinylated recombinant CMV-specific antigens and recombinant CMV-specific antigens labeled with a ruthenium complex for electrochemiluminescence detection.

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November 07, 2023 at 05:14PM Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

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November 07, 2023 at 05:01PM COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

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November 06, 2023 at 03:54PM Real-Time Oncology Review (RTOR)

Real-Time Oncology Review (RTOR) Draft Guidance for Industry

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November 07, 2023 at 02:28PM Vaccines and Related Biological Products Advisory Committee October 5, 2023 Meeting Announcement - 10/05/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) October 5, 2023 announcement and meeting materials.

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November 06, 2023 at 06:13PM Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

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November 06, 2023 at 04:08PM 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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November 03, 2023 at 05:43PM CBER Staff Fellow - Product/Chemistry, Manufacturing and Controls (CMC) Reviewer

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), is recruiting multiple Product/Chemistry, Manufacturing and Controls (CMC) Review Scientists as Staff Fellows.

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November 03, 2023 at 03:06PM Vaccination Is the Best Protection Against Measles

Measles is not a harmless childhood disease. It's dangerous and can be life-threatening. Our most effective public health measure against measles is prevention with the measles vaccine.

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November 02, 2023 at 04:40PM Biologics Research Projects

List of Biologics Research Areas

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November 02, 2023 at 02:04PM 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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November 02, 2023 at 02:03PM 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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November 01, 2023 at 09:29PM Blood Research

List of Blood Research Programs in Biologics

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November 01, 2023 at 05:09PM Fast Track Designation Request Performance

The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening condit

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November 01, 2023 at 02:08PM Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions

This guidance outlines FDA’s policies for certain limited modifications affecting the safety and effectiveness of devices approved through PMA or HDE.

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