April 28, 2023 at 09:55PM Pfizer-BioNTech COVID-19 Vaccines

Information about Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccine boosters are now FDA-authorized for all doses.

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April 28, 2023 at 09:14PM Cellular, Tissue, and Gene Therapies Advisory Committee May 12, 2023 Meeting Announcement - 05/12/2023

This is the main landing page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) May 12, 2023 Meeting Announcement and meeting materials.

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April 28, 2023 at 04:56PM 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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April 26, 2023 at 05:56PM FDASIA Section 705 Annual Reports

Annual Reports published by requirement of FDASIA Section 705

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April 27, 2023 at 10:39PM PREVNAR 20

Indication: Active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F,14, 15B, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

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April 28, 2023 at 02:45PM S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS

ICH - Safety

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April 27, 2023 at 01:57PM RDEA Pilot Program 2023 Public Workshop - 06/07/2023

The purpose of this public workshop is to discuss topics relevant to the development of endpoints for rare diseases.

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April 27, 2023 at 01:55AM 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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April 27, 2023 at 12:03AM FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile Infection

FDA approves Vowst, the first orally administered fecal microbiota product. Vowst is approved for the prevention of recurrence of Clostridioides difficile infection in individuals 18 years of age and older, following completion of antibacterial treatment for recurrent CDI.

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April 26, 2023 at 10:45PM BEXSERO

Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

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April 26, 2023 at 04:03PM Consumer Updates

Science-based health and safety information you can trust.

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April 26, 2023 at 02:11PM Blood Products Advisory Committee April 26, 2023 Meeting Announcement - 04/26/2023

This is the main page for the Blood Products Advisory Committee April 26, 2023 Meeting Announcement and meeting materials.

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April 25, 2023 at 09:04PM BIVIGAM

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

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April 25, 2023 at 07:20PM "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices

"Off-Label" Investigational Use Of Marketed Drugs, Biologics, and Medical Devices - Information Sheet

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April 24, 2023 at 08:36PM COVID-19 Bivalent Vaccines

FDA authorized bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including an additional dose or doses for certain populations

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April 21, 2023 at 11:33PM 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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April 21, 2023 at 10:12PM Jobs at the Center for Biologics Evaluation and Research (CBER)

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

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April 21, 2023 at 06:01PM 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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April 21, 2023 at 03:55PM 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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April 21, 2023 at 01:50PM BsUFA Performance Reports

BsUFA Performance Reports

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April 20, 2023 at 05:44PM FDA and NIH/NCI Center for Cancer Research: Advancing Drug Development in Myelodysplastic Syndromes - 05/16/2023

FDA and NIH/NCI Center for Cancer Research: Advancing Drug Development in Myelodysplastic Syndromes. Virtual 2-day free public workshop.

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April 20, 2023 at 04:44PM Consumer Updates

Science-based health and safety information you can trust.

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April 19, 2023 at 09:26PM Regenerative Medicine Advanced Therapy Designation

Eligibility requirements for a regenerative medicine advanced therapy (RMAT) designation. Information on when and where to submit the request is also provided.

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April 19, 2023 at 05:56PM COAGADEX

•Indicated in adults and children with hereditary Factor X deficiency for:
◦Routine prophylaxis to reduce the frequency of bleeding episodes
◦On-demand treatment and control of bleeding episodes
◦Perioperative management of bleeding in patients with mild and moderate hereditary Factor X deficiency


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April 19, 2023 at 05:39PM COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention

COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention

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April 18, 2023 at 08:02PM 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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April 18, 2023 at 06:51PM Ticks and Lyme Disease: Symptoms, Treatment, and Prevention

Lyme disease is on the rise. How can you prevent it? What are the symptoms, and what should you do if you think you or your pet have it?

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April 18, 2023 at 04:16PM Coronavirus (COVID-19) | CBER-Regulated Biologics

This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.

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April 18, 2023 at 01:24PM 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 section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.

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April 17, 2023 at 09:57PM 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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April 17, 2023 at 08:41PM HYQVIA

Indicated for the treatment of Primary Immunodeficiency (PI) in adults.

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April 17, 2023 at 08:25PM Pfizer-BioNTech COVID-19 Vaccines

Information about the Comirnaty, Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Updated COVID-19 vaccine boosters are now FDA-authorized.

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April 17, 2023 at 03:14PM Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

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April 13, 2023 at 03:57PM Understanding the Regulatory Terminology of Potential Preventative and Therapeutic Drugs for COVID-19

Consumers rely on the FDA for independent scientific reviews of medical products, including therapeutic drugs and vaccines. To meet the urgent need for products to treat or prevent COVID-19, the FDA has approved and authorized several preventative drugs, including vaccines and treatments.

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April 13, 2023 at 02:17PM 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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April 12, 2023 at 07:30PM 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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April 12, 2023 at 05:59PM Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)

COVID-19

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April 11, 2023 at 11:10PM 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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April 11, 2023 at 11:00PM Biologics Electronic Reading Room (eFOI)

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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China's military drills practice attacking Taiwan from Pacific coast - The Washington Post

1. China's military drills practice attacking Taiwan from Pacific coast  The Washington Post
2. Taiwan warns Chinese misstep could lead to 'uncontrollable' world war outbreak  Fox News
3. US responds as China practices 'sealing off' Taiwan in military drills | DW News  DW News
4. U.S., Chinese Aircraft Carriers Operating Near Taiwan, Chinese Carrier Shandong Launched 80 Fighter Missions in Weekend Drills - USNI News  USNI News
5. China simulates mass missile strikes on Taiwan in show of strength - BBC News  BBC News
6. View Full Coverage on Google News

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April 11, 2023 at 02:06PM Cellular, Tissue, and Gene Therapies Advisory Committee May 12, 2023 Meeting Announcement - 05/12/2023

This is the main landing page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) May 12, 2023 Meeting Announcement and meeting materials.

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Taiwan’s president condemns China drills as irresponsible - Al Jazeera English

1. Taiwan’s president condemns China drills as irresponsible  Al Jazeera English
2. Taiwan warns Chinese misstep could lead to 'uncontrollable' world war outbreak  Fox News
3. US responds as China practices 'sealing off' Taiwan in military drills | DW News  DW News
4. China military 'ready to fight' after drills near Taiwan  The Associated Press
5. China simulates mass missile strikes on Taiwan in show of strength - BBC News  BBC News
6. View Full Coverage on Google News

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April 10, 2023 at 10:05PM Afluria Quadrivalent, Afluria Quadrivalent Southern Hemisphere

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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April 07, 2023 at 10:22PM Afluria, Afluria Southern Hemisphere

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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April 10, 2023 at 07:41PM Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals

FDA is issuing this guidance to communicate its temporary policy for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency (PHE) declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

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April 07, 2023 at 06:56PM Administrative Guidances

This page lists Administrative Guidance documents.

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April 07, 2023 at 05:12PM Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting Announcement - 01/26/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) January 26, 2023 Meeting Announcement and meeting materials.

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April 07, 2023 at 01:44PM Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry

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April 06, 2023 at 10:56PM 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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April 06, 2023 at 10:36PM FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop - 03/14/2023

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual Workshop with cell and gene therapy stakeholders to discuss innovative manufacturing technologies and alternative analytical testing methods in the manufacture of cell therapy, gene therapy and tissue engineered medical products.

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April 06, 2023 at 09:14PM Special Protocol Assessment Guidance for Industry

Procedural

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April 05, 2023 at 06:08PM 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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April 05, 2023 at 05:06AM Center for Biologics Evaluation and Research (CBER) & Center for Drug Evaluation and Research (CDER): Real-World Evidence (RWE)

Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) Real-World Evidence (RWE)


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April 04, 2023 at 09:44PM 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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April 03, 2023 at 08:59PM BIMO/Team Biologics/Internet Surveillance/Other

This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

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March 31, 2023 at 04:48PM 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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April 03, 2023 at 06:36PM Application Submissions Guidances

This page lists Application Submissions Guidance documents.

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April 03, 2023 at 02:51PM International Activities

CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.

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April 03, 2023 at 02:46PM 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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Active weather pattern to bring range of hazards across the country - ABC News

1. Active weather pattern to bring range of hazards across the country  ABC News
2. Another Severe Weather Outbreak Possible Tuesday  The Weather Channel
3. Another widespread severe weather threat with strong tornadoes to impact 48 million in central US Tuesday  Yahoo News
4. Radio Station WHMI 93.5 FM — Livingston County Michigan News, Weather, Traffic, Sports, School Updates, and the Best Classic Hit  WHMI
5. Several tornadoes seen in Jacksonville area, but damage appears minor  Jacksonville Journal-Courier
6. View Full Coverage on Google News

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Tornado Little Rock: At least 26 dead, dozens hospitalized after Arkansas tornado outbreak and other violent storms across US - WPVI-TV

Tornado Little Rock: At least 26 dead, dozens hospitalized after Arkansas tornado outbreak and other violent storms across US  WPVI-TVView Full Coverage on Google News

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Communities face major destruction after large tornadoes tear through the South and Midwest, leaving at least 27 dead - CNN

1. Communities face major destruction after large tornadoes tear through the South and Midwest, leaving at least 27 dead  CNN
2. At least 26 dead after tornadoes rake US Midwest, South  Yahoo News
3. Deadly tornadoes rip through South, Midwest  FOX 11 Los Angeles
4. 'Strong EF-3' tears through Central Arkansas  KATV
5. Tornado Little Rock: At least 26 dead, dozens hospitalized after Arkansas tornado outbreak and other violent storms across US  WLS-TV
6. View Full Coverage on Google News

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Tornado Little Rock: At least 26 dead, dozens hospitalized after Arkansas tornado outbreak and other violent storms across US - WABC-TV

1. Tornado Little Rock: At least 26 dead, dozens hospitalized after Arkansas tornado outbreak and other violent storms across US  WABC-TV
2. Deadly tornadoes rip through South, Midwest  FOX 11 Los Angeles
3. At least 26 dead after tornadoes rake US Midwest, South  Yahoo News
4. National Weather Service confirms EF-3 tornado touched down in Little Rock Friday  KARK
5. Inside the tornado: Moment driver gets caught in Arkansas twister #shorts  The Sun
6. View Full Coverage on Google News

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Tornadoes Rip Wide Trail of Destruction in Midwest and South - The New York Times

1. Tornadoes Rip Wide Trail of Destruction in Midwest and South  The New York Times
2. At least 21 dead after deadly storms, tornadoes cause devastation in the South and Midwest  KTLA 5
3. Storms destroyed 72 homes in McNairy County  Tennessean
4. Deadly tornado outbreak updates: 21 deaths; power outage updates  USA TODAY
5. Four dead in Illinois after Friday's severe thunderstorms  WREX.com
6. View Full Coverage on Google News

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