Vaccines, Blood & Biologics

Featured

Influenza Vaccine for the 2019-2020 Season

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

Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry

Oct 15

Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review

Oct 02

Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus

FDA Guidance Search

Products & Establishments

Recalls

Make yourself heard by raising your hand

Advisory Committees

Center

Sep 23

Statement on final guidance to help advance development of novel treatments for ALS

Aug 06

Statement on data accuracy issues with recently approved gene therapy

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.

Learn More

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