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Imprese · 29/11/19991 min di lettura
Guidance for Industry on Drug Master Files for Bulk Antibiotic Drug Substances; Availability
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Riepilogo
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Drug Master Files for Bulk Antibiotic Drug Substances.'' This guidance is intended to assist those in industry whose approved applications for bulk antibiotic drug substances were converted to Type II drug master files (DMF's) as a result of the repeal of the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →