Ensuring Innovation Act Alters Eligibility for New Chemical Exclusivity
By EsqSocial Corporation 27/04/21
On April 23, 2021, President Biden signed into law The Ensuring Innovation Act (S. 415), which amends the requirements for New Chemical Entity (NCE) and Orphan Drug (ODE) exclusivities under the Federal Food, Drug, and Cosmetics Act (FDCA). The Ensuring Innovation Act exchanges the term “active ingredient” with the term “active moiety” in sections of the FDCA governing NCE and ODE....
By: Locke Lord LLP