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USFDA Guidance update on Generic Drug Application Submissions, Labeling, and Review

FDA published a series of guidances on January 26, 2022 focussing on Generic Drug Application Submissions, Labeling, and Review. These guidances bring greater efficiency and transparency to the generic drug review process, which helps spur competition and improves consumer access to the medicines they need at affordable prices.

These guidances support FDA’s Drug Competition Action Plan (DCAP), which encourages robust and timely market competition for generic drugs.

  1. FDA first issued Information Requests and Discipline Review Letters final guidance that describes how the agency issues and uses information requests (IRs) and discipline review letters (DRLs) during the assessment of an original abbreviated new drug application (ANDA).

  2. FDA also revised the accompanying Manual of Policies and Procedures (MAPP), Issuance of Information Requests and/or Discipline Review Letters for ANDAs. The MAPP describes how the generic drug program issues IRs and DRLs for ANDAs, which will help enhance consistency and predictability in FDA’s communications with the industry.

  3. FDA’s updated its draft guidance Revising ANDA Labeling Following Revision of the RLD Labeling, which provides recommendations for updating labeling for ANDAs following approved revisions to the labeling of a reference listed drug (RLD). This guidance also includes how to monitor for RLD labeling updates, how to submit labeling updates to both unapproved and approved ANDAs to conform to RLD labeling updates, and other considerations for submitting a labeling update to FDA.

  4. Good ANDA Submission Practices was also updated and it highlights common, recurring deficiencies in ANDAs that may lead to approval delays. This guidance also provides recommendations on ways potential and current applicants can avoid these common deficiencies, which may reduce the number of review cycles necessary to meet ANDA approval requirements.


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