New drugs and therapeutic biological products often signify novel treatment options and advancements in healthcare for the American population. Each year, CDER shares a complete list of all novel drug approvals for the prior year. The FDA’s Center for Drug Evaluation and Research (CDER) plays a crucial role in providing clarity to drug developers regarding study design elements and required data in drug applications, ensuring a comprehensive assessment. This process hinges on CDER’s deep understanding of the underlying science, testing and manufacturing protocols, and the specific diseases and conditions targeted by these new products. Within this framework, certain drugs are designated as new molecular entities (NMEs) for FDA review, representing compounds with active moieties not previously approved by the agency, offering promising new therapies. While some NMEs may contain active moieties closely related to previously approved products, the FDA’s classification of drugs as NMEs for review purposes remains distinct from its determination of whether a drug qualifies as a “new chemical entity” (NCE) under the Federal Food, Drug, and Cosmetic Act.1
Access the complete list of novel drug approvals for 2023 here.
References
- Research, C. F. D. E. A. (2024, February 16). Novel drug approvals for 2023. U.S. Food And Drug Administration. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023
Disclaimers
- The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
- Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
- No official support by any organization(s) has been provided or should be inferred
