New FDA guidance: Good ANDA Submission Practices
The US Food and Drug Administration (FDA) has published a new guidance for industry: Good ANDA Submission Practices.
“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.”
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This guidance describes common, recurring deficiencies identified during FDA’s substantive assessment of ANDAs with respect to:
- patents and exclusivities,
- labeling,
- product quality, and
- bioequivalence (BE).
This guidance also provides recommendations to applicants on how to avoid these deficiencies.
FDA comprehensively communicates deficiencies identified during a substantive review of an ANDA in complete response letters. Applicants may address the deficiencies identified by FDA by submitting an amendment to their application.
Read more in the FDA guidance.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
