Vaccines, Blood & Biologics

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Coronavirus (COVID-19) | CBER-Regulated Biologics

Establishment of the Office of Therapeutic Products

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Allergenics

Allergen Extracts, Allergen Patch Tests, Antigen Skin Test

Blood & Blood Products

Blood, Blood Components, Blood Bank Devices, Blood Donor Screening Tests

Cellular & Gene Therapy Products

Gene-based Treatments, Cell-based Treatments, Cloning

Guidance, Compliance & Regulatory Information

Guidance, Rules, SOPPS, Establishment Registration, Enforcement, Compliance

Tissue & Tissue Products

Bone, Skin, Corneas, Ligaments, Tendons, Stem Cells, Sperm, Heart Valves

Vaccines

Vaccines for Use in Children and Adults, Tuberculin Testing

Xenotransplantation

Transplantation of Non-Human Cells, Tissues or Organs Into a Human

Development & Approval Process

Advertising & Labeling, IND, Expanded Access, PMA, BLA, NDA, 510(k)

Safety & Availability

Recalls, Shortages, Biological Product Deviation Reporting, Adverse Event Reporting, HIV Home Test Kits

International Activities

Regulatory Harmonization/ Convergence, WHO Engagements, Resources for Foreign Regulators

Science & Research

Research by FDA Staff to Evaluate and Enhance the Safety of Biologic Products

Resources for You

Information for Consumers, Health Professionals, Industry

News & Events

Latest news and event information from the Center for Biologics Evaluation and Research at FDA

Fecal Microbiota Products

Information about Fecal Microbiota Products

About the Center for Biologics Evaluation and Research (CBER)

Information About CBER

Center

Mar 17

Pharmacogenomic Data Submissions

Mar 16

Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry

Mar 15

Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

FDA Guidance Search

Products & Establishments

Recalls

Make yourself heard by raising your hand

Advisory Committees

Center

Mar 14

Coronavirus (COVID-19) Update: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age

Jan 27

FDA Proposes Individual Risk Assessment for Blood Donations, While Continuing to Safeguard U.S. Blood Supply

More Press Announcements

Impact of Severe Weather Conditions on Biological Products

CBER is providing interested persons with information concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or flood conditions.

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What's New for Biologics

Latest news from the Center for Biologics and Evaluation at FDA.

Follow CBER on Twitter

CBER's main goal for Twitter is to provide up-to-date information to consumers, health professionals, regulated industry and other interested stakeholders about CBER regulated products.

Workshops, Meetings & Conferences

FDA's Center for Biologics Evaluation and Research (CBER) sponsors or co-sponsors meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

Contact Us

Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002

ocod@fda.hhs.gov

(800) 835-4709

(240) 402-8010

Hours Available

Food and Drug Administration

Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave
Silver Spring, MD 20993
United States

U.S. Food and Drug Administration