GDUFA Guidance for Industry on ANDA Submissions

The Generic Drug User Fee Amendments (GDUFA) guidance outlines the process for Abbreviated New Drug Application (ANDA) submissions and amendments, detailing categories, assessment goals, and their application.

Key Points:

• Categories of Amendments: Clarifies types of amendments and their assessment timelines.
• Assessment Goals: Addresses changes to classifications, deferred and unsolicited amendments, and final approval requests.
• Deficiencies: The FDA maintains a list of potential major deficiencies that could lead to a Complete Response Letter (CRL). Unresolved issues may result in either a major or minor CRL.
• Information Requests (IRs): The FDA aims to resolve deficiencies via IRs and Discipline Review Letters (DRLs) before issuing a CRL.
• Preclinical Studies: Generally not required for ANDA approvability; new preclinical studies may indicate that ANDA is not the appropriate submission route.
• Amendment Classification: ANDA amendments will be classified as major or minor, affecting their goal dates and assessment processes.

Source: https://www.fda.gov/media/89258/download

Region: United States of America