Vaccines, Blood & Biologics

Biologics Post-Market Activities

FDA continues to assure product safety and efficacy even after a product is approved.  These post-market activities include lot release (for some products), post-marketing adverse event reporting, and post-marketing study commitments (also known as Phase IV studies).

Approvals & Clearances

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 01/05/2010
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.