Vaccines, Blood & Biologics

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Coronavirus (COVID-19) | CBER-Regulated Biologics

CBER’s Document Control Center (DCC) will not process any submissions received by mail or courier including submissions provided on paper and electronic media (e.g., CDs, USB drives) until further notice. Submissions may be sent through the Electronic Submission Gateway or in some cases by e-mail. Please see the Letter to CBER Sponsors, Applicants and Regulated Entities.

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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 and Evaluation at FDA

Center

Jul 01

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking

Jun 30

Development and Licensure of Vaccines to Prevent COVID-19

Jun 29

Development of Anti-Infective Drug Products for the Pediatric Population

FDA Guidance Search

Products & Establishments

Recalls

Make yourself heard by raising your hand

Advisory Committees

Center

Jun 30

Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines

Jun 10

Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19

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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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