Vaccines, Blood & Biologics

Industry (Biologics)

CBER’s Policies, Procedures, and Review Resources

This webpage provides important resources related to the regulatory framework of products regulated by CBER, including policies, procedures, and review resources.

CBER reviews applications for new products, new indications for already approved products, and product-related changes. This requires evaluating submitted scientific and clinical data to determine whether the product meets CBER's standards for approval. After a thorough assessment of the data, CBER makes a decision based on the risk-benefit for the intended population and the product's intended use. CBER's authority resides in the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act.
 

Approvals & Clearances

More Information

Contact FDA

(800) 835-4709
(240) 402-8020
Manufacturers Assistance and Technical Training Branch (CBER)

Division of Manufacturers Assistance and Training

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: 08/17/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English