January 27, 2021 at 09:32PM New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products

Historically, CBER has regulatory jurisdiction over some NDA products. Most NDAs are reviewed by the Center for Drug Evaluation and Research (CDER). There are only a few ANDAs currently regulated at CBER, e.g., ANDAs related to blood transfusion products. Most ANDAs are reviewed by CDER.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2YsbHE1