March 27, 2024 at 07:12PM About the FDA and How You Can Get Involved

About the FDA and How You Can Get Involved

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March 29, 2024 at 04:54PM Vaccines and Related Biological Products Advisory Committee February 28-March 1, 2023 Meeting Announcement - 02/28/2023

This is the main landing page for the Vaccines and Related Biological Products Advisory Committee February 28 - March 1, 2023 Meeting Announcement and meeting materials.

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March 28, 2024 at 06:22PM Vaccines and Related Biological Products Advisory Committee March 5, 2024 Meeting Announcement - 03/05/2024

This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) March 5, 2024 Meeting announcement and meeting materials.

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March 28, 2024 at 02:53PM Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry

Clinical Pharmacology

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March 27, 2024 at 06:48PM 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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March 26, 2024 at 06:57PM Transmissible Spongiform Encephalopathy Infectivity in Blood and Other Biologicals: Strategies for Detection, Decontamination and Removal

A description of Luisa Gregori's research program and related publications.

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March 26, 2024 at 04:04PM CBER 2024 Orphan Approvals

CBER 2024 Orphan Approvals

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March 26, 2024 at 03:39PM 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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March 25, 2024 at 08:10PM 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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March 25, 2024 at 03:34PM Animal Rule Information

Links to information about the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible

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March 25, 2024 at 02:15PM Consumer Updates

Science-based health and safety information you can trust.

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March 22, 2024 at 01:52PM Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable

FDA intends to exercise enforcement discretion with respect to its current regulations governing the requirement for informed consent when human specimens are..

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March 21, 2024 at 08:03PM Facts about COVID-19

Facts about COVID-19 vaccines, including ingredients, safety and more

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March 21, 2024 at 01:46PM 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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March 20, 2024 at 02:50PM Malaria

This page contains information on Malaria infectious disease tests with supporting documents

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March 19, 2024 at 06:50PM Infectious Disease Tests

Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

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March 20, 2024 at 01:39PM 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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March 19, 2024 at 09:08PM FDA Roundup: March 19, 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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March 19, 2024 at 08:28PM Artificial Intelligence and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER

Use of Artificial Intelligence and Machine Learning (AI/ML) has rapidly become an important component of everyday life. This includes using AI/ML in the development of Medical Products, including Biologics. This page provides an overview of CBER's activity in AI/ML.

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March 18, 2024 at 07:24PM ABRYSVO

ABRYSVO is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.


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March 18, 2024 at 05:37PM Enforcement Actions (CBER)

The Center for Biologics Evaluation and Research (CBER) may issue several types of regulatory action letters. These letters are ordinarily issued to biological product manufacturers in the effort to stop practices found to be in violation of the regulations and to promote corrective action.

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Chicago to begin evicting migrants from shelters Sunday - NBC News

1. Chicago to begin evicting migrants from shelters Sunday  NBC News
2. Chicago will begin evicting migrants this weekend  WBEZ Chicago
3. Chicago migrants: Majority of evictions at migrant shelters on hold as city grapples with measles outbreak  WLS-TV
4. Johnson announces ‘case-specific’ exemptions to 60-day migrant shelter limit  WGN TV Chicago
5. Chicago migrant shelter evictions to begin despite measles outbreak  FOX 32 Chicago

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Chicago will begin evicting migrants this weekend - WBEZ Chicago

1. Chicago will begin evicting migrants this weekend  WBEZ Chicago
2. Chicago migrants: Majority of evictions at migrant shelters on hold as city grapples with measles outbreak  WLS-TV
3. Johnson announces ‘case-specific’ exemptions to 60-day migrant shelter limit  WGN TV Chicago
4. Chicago migrant shelter evictions to begin despite measles outbreak  FOX 32 Chicago
5. Migrant evictions to begin Sunday; families in shelters get a reprieve  Chicago Sun-Times

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Chicago to begin evicting migrants from shelters Sunday - NBC News

1. Chicago to begin evicting migrants from shelters Sunday  NBC News
2. Chicago will begin evicting migrants this weekend  WBEZ Chicago
3. Chicago migrants: Majority of evictions at migrant shelters on hold as city grapples with measles outbreak  WLS-TV
4. Johnson announces ‘case-specific’ exemptions to 60-day migrant shelter limit  WGN TV Chicago
5. Chicago migrant shelter evictions to begin despite measles outbreak  FOX 32 Chicago

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Chicago will begin evicting migrants this weekend - WBEZ Chicago

1. Chicago will begin evicting migrants this weekend  WBEZ Chicago
2. Chicago migrants: Majority of evictions at migrant shelters on hold as city grapples with measles outbreak  WLS-TV
3. Johnson announces ‘case-specific’ exemptions to 60-day migrant shelter limit  WGN TV Chicago
4. Chicago migrant shelter evictions to begin despite measles outbreak  FOX 32 Chicago
5. Migrant evictions to begin Sunday; families in shelters get a reprieve  Chicago Sun-Times

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March 15, 2024 at 06:55PM 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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March 15, 2024 at 04:35PM 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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March 15, 2024 at 11:55AM GARDASIL 9

Product approval information for Human Papillomavirus 9-valent Vaccine, Recombinant also known as Gardasil 9.

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March 15, 2024 at 01:46PM Harnessing the Potential of Artificial Intelligence

At the FDA, we’ve been working for years to anticipate and prepare for the challenges of Artificial Intelligence (AI), and also to harness its potential.

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March 14, 2024 at 08:26PM 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 14, 2024 at 02:13PM Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff

This guidance describes the mechanisms through which submitters can request interactions with FDA regarding potential or submitted medical device submissions.

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March 14, 2024 at 01:52PM 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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March 13, 2024 at 08:40PM 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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Wildfire outbreak and major winter storm possible Wednesday - NBC News

1. Wildfire outbreak and major winter storm possible Wednesday  NBC News
2. Colorado snow forecast: How many inches (or feet) of snow to expect this week  The Denver Post
3. Winter storm warning for Denver and Boulder: How much snow could fall  The Washington Post
4. Denver weather: Rain turns to snow Wednesday night ahead of Pinpoint Weather Alert Day Thursday  FOX 31 Denver
5. Winter Storm Warning in Colorado: Denver could see major snowfall  9News.com KUSA

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March 13, 2024 at 02:33PM Devices Guidances

This page lists Medical Device Guidance documents.

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March 12, 2024 at 12:59PM FDA CBER Webinar: Considerations for the Development of CAR T Cell Products - 03/07/2024

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public webinar on Thursday, March 7 at 1:00 p.m.

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March 12, 2024 at 04:07PM Roster of the Blood Products Advisory Committee

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

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March 12, 2024 at 02:20PM Human Microbes - 672740 - 02/09/2024

CGMP/Deviations/Biologics License Application (BLA)


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March 12, 2024 at 02:05PM Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act

This draft guidance identifies the cybersecurity information FDA considers to generally be necessary for cyber devices under section 524B of the FD&C Act.

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March 11, 2024 at 01:32PM 2024 Meeting Materials, Blood Products Advisory Committee

This is the main page for the 2024 Blood Products Advisory Committee (BPAC) announcements and meeting materials.

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March 08, 2024 at 04:46PM AMTAGVI

Lifileucel for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

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March 08, 2024 at 01:44AM U.S. Public Health Response to the Zika Virus: Continuing Challenges - 05/22/2017

Testimony of Luciana Borio, M.D., FDA Acting Chief Scientist, before the Subcommittee on Oversight and Investigations, House Energy and Commerce Committee, May 23, 2017

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March 07, 2024 at 11:58PM 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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March 07, 2024 at 03:32PM Supporting the Production of Safe and Effective Influenza Vaccines

A description of Zhiping Ye's research program and related publications.

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March 07, 2024 at 02:57PM Bacterial Vaccine Safety: Biomarkers of Virulence and Attenuation in Bordetella Pertussis (Whooping Cough) and Anthrax Bacteria

A description of E. Scott Stibitz's research program and related publications.

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March 07, 2024 at 02:49PM Development of Quantitative Assays to Evaluate the Safety of Cell Substrates and Vaccines

A description of Keith Peden's research program and related publications.

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March 06, 2024 at 03:26PM Identification of Targets for Development of Vaccines and Biological Therapies Against Gastrointestinal Pathogens

Identification of Targets for Development of Vaccines and Biological Therapies Against Gastrointestinal Pathogens

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March 06, 2024 at 02:54PM Developing Tests to Detect Evidence of Protective Immune Responses Generated by Vaccines for Respiratory Viruses That Infect Infants, Children and the Elderly

A description of Judy Beeler's research program and related publications.

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March 05, 2024 at 08:19PM FDA CBER Webinar: Human Gene Therapy Products Incorporating Human Genome Editing - 02/29/2024

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public webinar on Thursday, February 29 at 1:00 pm.

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March 05, 2024 at 02:56PM 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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March 05, 2024 at 12:55AM 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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March 04, 2024 at 11:09PM Kedbumin

Product approval information is indicated for:
o Hypovolemic shock
o Hypoalbuminemia
o Prevention of central volume depletion after paracentesis due to cirrhotic ascites
o Ovarian Hyperstimulation Syndrome (OHSS)
o Adult Respiratory Distress Syndrome (ARDS)
o Burns
o Hemodialysis patients undergoin

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March 04, 2024 at 06:45PM 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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March 04, 2024 at 04:59PM ASCENIV

Indicated for the treatment of Primary Immunodeficiency Diseases (PIDD)

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March 04, 2024 at 04:48PM BIVIGAM

Product approval information is indicated for treatment of Primary Humoral Immunodeficiency

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March 01, 2024 at 02:12PM 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 a measles vaccine. Vaccines approved by the FDA for the prevention of measles are proven both safe and effective.

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March 01, 2024 at 02:21PM Information for Health Professionals on “Partial Heart Transplantation"

The Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regulates human cells, tissues, and cellular and tissue-based products, or HCT/Ps. These include tissues derived from organs.

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March 01, 2024 at 01:41AM Tissue & Tissue Products

CBER regulates human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P.

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