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Imprese · 08/06/19981 min di lettura
Draft Guidance for Industry on Stability Testing of Drug Substances and Drug Products; Availability
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Riepilogo
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Stability Testing of Drug Substances and Drug Products.'' The draft guidance provides recommendations regarding the stability studies that should be performed to support new drug applications, abbreviated new drug applications, investigational new drug applications, biologics license applications, product license applications, and supplements to these applications.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →