®: CRE Regulatory Action of the Week
FDA Amends Biological Product Definition and Defines the Statutory Term Protein
The U.S. Food and Drug Administration has issued a final rule amending its regulation that defines biological product. This final rule incorporates changes made by the Biologics Price Competition and Innovation Act of 2009 and the Further Consolidated Appropriations Act of 2020. It also provide FDA interpretation of the statutory term protein. Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated. This rule is effective March 23, 2020. Click here for more information and relevant links.