Zdrowie i gospodarka · 21/02/2020

FDA Issues Final Rule to Define Biological Product and Protein

The Food and Drug Administration has issued a final rule to update its definition of a biological product, incorporating changes from the Biologics Price Competition and Innovation Act of 2009 and the Further Consolidated Appropriations Act of 2020, and to clarify the meaning of protein as an alpha amino acid polymer with a specific sequence greater than 40 amino acids in size.