July 31, 2023 at 03:50PM OCTAGAM

Product approval information is indicated for the treatment of chronicimmune purpura (ITP) in adults

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July 28, 2023 at 10:31PM FDA Roundup: July 28, 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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July 28, 2023 at 08:02PM 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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July 28, 2023 at 04:25PM LANTIDRA

Product information for LANTIDRA

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July 28, 2023 at 03:46PM 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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July 27, 2023 at 06:25PM HPC, Cord Blood - LifeSouth

For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myelo

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July 27, 2023 at 02:43PM 2023 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

This is the main landing page for the CBER 2023 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC).

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July 26, 2023 at 03:01PM Clinical Investigator Inspection List T-Z

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

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July 25, 2023 at 10:13PM FDA Roundup: July 25, 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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July 25, 2023 at 10:04PM Center for Biologics Evaluation and Research Patient Engagement Program

Patient input is a critical part of CBER’s understanding of diseases and conditions. Engaging with patients and listening to their perspectives on their diseases and treatments may help the center advance patient-focused medical product development.

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July 25, 2023 at 08:37PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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July 25, 2023 at 04:35PM Clinical Trials: The Patient Experience - 04/13/2023

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a public virtual workshop on Thursday, April 13 from 11:00 a.m. – 3:00 p.m. ET.

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July 25, 2023 at 03:20PM Stratus Biosystems, LLC dba CellGenuity Regenerative Science - 631303 - 06/05/2023

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

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July 24, 2023 at 02:25PM 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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July 21, 2023 at 10:01PM FDA Roundup: July 21, 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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July 21, 2023 at 08:06PM LANTIDRA

Product information for LANTIDRA

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July 20, 2023 at 08:39PM 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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July 21, 2023 at 05:29PM ROCTAVIAN

Product information for ROCTAVIAN

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July 21, 2023 at 02:19PM 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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July 20, 2023 at 10:24PM KINRIX

Changes to your package insert to the Dosage and Administration section regarding visual inspection by the user for cracked vials or syringes prior to administration of the vaccine and non-use of product should those conditions exist.

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July 20, 2023 at 08:16PM 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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July 20, 2023 at 04:40PM INFANRIX

Product approval information for Diphtheria Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed also known as Infanrix.

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July 20, 2023 at 02:13PM 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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July 19, 2023 at 07:39PM Certificate to Foreign Government for Device Not Exported from the United States (CBER)

This is the page for the CBER Certificate to Foreign Government for Device Not Exported from the United States.

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July 19, 2023 at 04:08PM Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Announcement - 06/15/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting June 15, 2023 announcement and meeting materials.

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July 19, 2023 at 04:07PM Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Announcement - 05/18/2023

This is the main landing page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) May 18, 2023 Meeting announcement and meeting materials.

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July 19, 2023 at 03:56PM 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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July 19, 2023 at 03:53PM 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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July 18, 2023 at 09:10PM American Fertility Medical Center, Genetic Infertility & Andrology Lab - 605068 - 04/02/2020

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

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July 18, 2023 at 07:53PM Vibrant Health Care, Inc. - 608426 - 11/18/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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July 18, 2023 at 12:42PM 21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics - 607654 - 07/21/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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July 14, 2023 at 02:35PM 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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July 14, 2023 at 08:30PM Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere, Fluzone High-Dose Quadrivalent Southern Hemisphere

For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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July 14, 2023 at 05:00PM 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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July 13, 2023 at 10:45PM 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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July 13, 2023 at 09:41PM Biological Product Deviations

Includes Human Tissue and Cellular and Tissue-Based Product (HCT/P) Deviation Reporting.

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July 13, 2023 at 09:28PM General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486

For use by biological product manufacturers to report biological product deviations (BPD) that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also for use by Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P) manufacturers to report HCT/P deviations in accordance with 21 CFR 1271.350(b).

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July 13, 2023 at 08:32PM ELEVIDYS

Treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

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July 13, 2023 at 02:37PM Cellular & Gene Therapy Guidances

This page contains a listing of cellular and gene therapy guidances.

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July 13, 2023 at 02:37PM Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products

This is the Draft Guidance for Industry, Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products

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July 12, 2023 at 06:17PM 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 conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling submission" for a marketing application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.

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July 12, 2023 at 05:28PM DENGVAXIA

DENGVAXIA For the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratoryconfirmed previous dengue infection and living in endemic areas.

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July 12, 2023 at 05:23PM eSubmitter Application History

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

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July 12, 2023 at 04:13PM 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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July 12, 2023 at 03:35PM Real-World Evidence (RWE) Resources

The table lists public training resources, including webinars, presentation, and workshops.

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July 12, 2023 at 03:28PM 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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July 12, 2023 at 03:24PM RWD and RWE-focused Demonstration Projects

To promote shared learning and understanding with external stakeholders, FDA continues to oversee and support numerous demonstration (i.e., research) projects through multiple venues and programs including the broad agency announcements, funding opportunity announcements, CERSI grants

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July 11, 2023 at 09:03PM Clinical Guidances

This page lists Clinical Guidance documents.

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July 11, 2023 at 06:47PM Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

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July 11 2023 at 03:20PM Row1 Inc. dba Regenative Labs - 638823 - 06/21/2023

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)


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July 11 2023 at 03:06PM 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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July 10 2023 at 09:05PM 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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July 07 2023 at 10:32PM FDA Roundup: July 7 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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July 06 2023 at 09:51PM FluMist Quadrivalent

For active immunization of individuals 2 through 49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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July 06 2023 at 08:54PM Flucelvax Quadrivalent

For active immunization of children and adolescents 4 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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July 06 2023 at 06:23PM Consumer Updates

Science-based health and safety information you can trust.

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July 03 2023 at 12:14PM FluLaval Quadrivalent

For active immunization of persons 6 months of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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July 05 2023 at 07:46PM 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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4th of July shootings 2023: Gun violence taints holiday across the US - USA TODAY

1. 4th of July shootings 2023: Gun violence taints holiday across the US  USA TODAY
2. Congress reacts to July Fourth outbreaks of gun violence  CBS News
3. Township Council, Administration Condemn Independence Day Weekend Shootings Throughout U.S.  TAPinto.net
4. This July 4th, our nation needs freedom from unfettered gun violence  Chicago Sun-Times
5. Baltimore shooting shows limits of our freedom this July Fourth  The Washington Post
6. View Full Coverage on Google News

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July 05 2023 at 04:23PM OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products - 08/30/2023

CBER and OTP is hosting its next virtual town hall on Wednesday, August 30, 2023 to answer stakeholder questions related to nonclinical assessment of cell and gene therapy products. Experts from OTP’s Office of Pharmacology/Toxicology will be on-hand to answer questions.

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July 03 2023 at 11:18PM DENGVAXIA

DENGVAXIA For the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratoryconfirmed previous dengue infection and living in endemic areas.

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July 03 2023 at 09:31PM Fluarix Quadrivalent

For active immunization of persons 6 months and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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July 03 2023 at 07:09PM 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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July 03 2023 at 07:01PM 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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July 03 2023 at 03:45PM Seasonal Information for Influenza Virus Vaccine

Seasonal Information for Influenza Virus Vaccine

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July 03 2023 at 03:11PM Influenza Vaccine for the 2023-2024 Season

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, on March 3, 2022, to select the influenza viruses for the composition of the influenza vaccine for the 2023-2024 U.S. influenza season.

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