Issue Date: January 26, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): Drug Competition Action Plan, Generic Drugs
Status: Final
Good ANDA Submission Practices Guidance for Industry
This guidance is 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.
Download the Guidance Document
