FDA Guidance for Industry: ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA

Titel:
FDA Guidance for Industry: ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA
Herkunft/Verlag:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404440.pdf

Inhalt:
This guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to the Food and Drug Administration under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).

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