What are the requirements for submitting a BLA?
A BLA is submitted by an applicant (manufacturer) and must contain data derived from non-clinical laboratory and clinical studies which, demonstrate that the manufactured product meets prescribed requirements of safety, purity, and potency (21 CFR Part 601.2).
What does BLA stand for in FDA filling of biological formulations?
Biologics License Application
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
What is CDER and CBER?
CDER is the lead Center for regulation of human drugs that are regulated by FDA under the authority of the Federal Food Drug and Cosmetic (FD&C) Act. CBER is the lead center for regulating biological products.
How long does it take to submit a BLA?
Current FDA performance goals under the Prescription Drug User Fee Act (PDUFA) stipulate that FDA intends to review and act on 90% of standard NDA and BLA submissions within 10 months of the filing date. The goal for priority review applications is 6 months.
What is CBER FDA?
CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.
What is the full form of CBER?
What is the Center for Biologics Evaluation and Research (CBER)? CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.
When was CBER formed?
July 1, 2002 marked the passage of the 1902 Biologics Control Act, which gave the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) the authority to regulate biological products and ensure their safety for the American public.