Today the U.S. Food and Drug Administration issued a proposed rule to amend its regulations on the use of master files for biological products. The proposed rule, if finalized, would allow certain applications for biological products approved under the Federal, Food, Drug, and Cosmetic Act to continue incorporating by reference information on drug substances, drug substance intermediates, or drug products contained in drug master files (DMF) after the approved applications for those products are deemed to be licenses under the Public Health Service Act (PHS Act) on March 23, 2020. The proposed rule would also codify the FDA’s existing practice that an application for ... |
No comments:
Post a Comment