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Novel Drug Approvals for 2023
by FDA on March 22, 2023 at 8:53 pm
Each year, CDER approves a wide range of new drugs and biological products.
CDER Manual of Policies & Procedures | MAPP
by FDA on March 22, 2023 at 8:38 pm
CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures.
Ongoing | Cancer Accelerated Approvals
by FDA on March 22, 2023 at 7:56 pm
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.

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