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Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER and organized by calendar...
As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States
This report describes CDER’s 2024 notable drug approvals, which are actions we consider likely to have a significant impact on patient care and public health.
Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2015.
See Drugs@FDA for information about all of CDER’s approved drugs and biological products. FDA Novel Drug Therapy Approvals for 2025 Export Excel ... Showing 1 to 35 of 35 entries
Table of Substrates, Inhibitors and Inducers (including: CYP Enzymes, Clinical index drugs, transporters, and examples of clinical substrates, inhibitors, and inducers).
The New Drug Therapy Approvals report summarizes CDER’s 2022 approvals and spotlights examples of notable treatments.
Modernized review and approval methods to ensure safety. CDER’s 21st Century Review guides CDER’s performance and accountability standards when reviews of new drugs involve multiple...
Each year since 2011 we have developed a novel new drugs report that highlights the new products.
