March 16, 2023 at 02:59PM 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.

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