FDA takes new step to help advance the transition of certain biological products


27 June 2019 - Today the U.S. FDA issued a proposed rule to amend its regulations on the use of master files for biological products. 

The proposed rule, if finalised, 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 23 March 2020. 

The proposed rule would also codify the FDA’s existing practice that an application for a biological product under the PHS Act may rely on a master file, except for information on drug substances (active pharmaceutical ingredient, or API), drug substance intermediates (a material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API), or drug products (finished dosage forms, such as tablets or capsules).

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Michael Wonder

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Michael Wonder