Bill > S1636

This bill amends the Federal Food, Drug, and Cosmetic Act to clarify the meaning of "new chemical entity" in the context of drug exclusivity. Specifically, it replaces references to "active ingredient" with "active moiety" as defined by the FDA, which refers to the molecule responsible for the drug's physiological or pharmacological action. The bill aims to ensure that drug exclusivities are granted based on the novelty of the active moiety, rather than simply the salt or ester form of a previously approved active ingredient.

Health and Social Services

https://www.congress.gov/bill/116th-congress/senate-bill/1636/all-info