FDA Good ANDA Submission Practices Guidance

FDA has published a guidance, Good ANDA Submission Practices, to assist applicants preparing to submit ANDAs to the agency. The document highlights common recurring deficiencies that may lead to a delay in approving an ANDA. It also makes recommendations to applicants on how to avoid the deficiencies to minimize the number of review cycles needed for approval.

The guidance covers Introduction, Background, Patent and Exclusivity Deficiencies, Labeling Deficiencies, Product Quality Deficiencies, and Bioequivalence Deficiencies.

The agency also published a second guidance, Information Requests and Discipline Review Letters Under GDUFA, explaining how FDA will issue and use an information request and/or a discipline review letter during the assessment of an original 505(j) ANDA. The document does not apply to an amendment made in response to a complete response letter, a supplement, or an amendment to a supplement.