Sunday, 1 April 2018

US Food and Drug Administration Good ANDA submission practices



This draft guidance intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs).

This guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA. It also makes recommendations to applicants on how to avoid these deficiencies with the goal of minimizing the number of review cycles necessary for approval.

FDA is also issuing a Good ANDA Assessment Practices Manual of Policies and Procedures which establishes good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality to increase their operational efficiency and effectiveness.

See: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM591134.pdf


Posted by Dr. Tim Sandle

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