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Geschäft · 15.5.20141 Min. Lesezeit
Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability
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Zusammenfassung
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers." It replaces the draft guidance with the same name that published on August 27, 2013 (78 FR 52931). This guidance clarifies stability testing recommendations discussed in International Conference on Harmonisation (ICH) stability guidances Q1A(R2) through Q1E for abbreviated new drug applications (ANDAs) and provides responses to public comments in a questions-and-answers format.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →