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Geschäft · 29.11.19991 Min. Lesezeit
Guidance for Industry on Drug Master Files for Bulk Antibiotic Drug Substances; Availability
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Zusammenfassung
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.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →