Recently, the FDA published three (03) guidance documents that focus on generic drug application submissions, labeling, and review. Among the three (03) guidance documents, two (02) are final drafts, and one (01) is a revised draft, which supports FDA’s Drug Competition Action Plan (DCAP) that was first announced in 2017. The guidance documents are a part of the FDA’s continued effort to bring greater efficiency and transparency to the generic drug review process, which helps spur competition and improves consumer access to medicines at affordable prices. Let’s dive into the details.

Final Guidance: Good Abbreviated New Drug Applications (ANDAs) Submission Practices

Firstly, the two final drafts intend to assist applicants in preparing ANDA submissions. The first of the two guidance documents highlights the common, recurring deficiencies that may lead to a delay in the ANDA approvals, and provide recommendations to applicants on how to avoid the deficiencies and aim for submitting high-quality ANDA applications to the FDA by minimizing the number of review cycles for approval.

The deficiencies are identified during the FDA’s substantive assessment of ANDAs with respect to:

  • Patents and exclusivities
  • Labeling
  • Product quality
  • Bioequivalence (BE)

Final Guidance: Information Requests (IRs) and Discipline Review Letters (DRLs) under Generic Drug User Fee Amendments (GDUFA)

The other final guidance gives an overview of how IRs and DRLs are used during the assessments of original ANDAs. The FDA first issued IRs and DRLs under the GDUFA as draft guidance in 2017. As described in this guidance, IRs and DRLs will improve the predictability, transparency, and efficiency of the FDA’s assessment process. Also, they intend to provide applicants feedback about potential deficiencies in their submissions around the mid-point of the review period so that the applicants will have an opportunity to resolve the issues in that same assessment cycle. In addition, the FDA revised the accompanying Manual of Policies and Procedures (MAPP), which describes how the generic drug program issues IRs and DRLs for ANDAs, and thereby enhances consistency and predictability in the FDA’s communications with industry.

Revised Draft Guidance: ANDA Labeling

Firstly, the FDA issued this draft guidance in April 2000 and has updated it with details on obtaining information on Reference Listed Drug (RLD) labeling changes and submitting revised ANDA labeling to FDA, consistent with the GDUFA procedures. The document provides recommendations for updating labeling for ANDAs following approved revisions to the labeling of an RLD, including:

  • how to monitor 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 the FDA

As recommended by the FDA, an ANDA holder must update their labeling after the Agency has approved relevant changes to the labeling of the corresponding RLD. The FDA expects that this guidance will help ensure timely ANDA approvals and enable patient access to generic drugs quickly by facilitating prompt submission of labeling changes to unapproved ANDAs to conform to RLD labeling updates.

On a final note, the FDA’s top priorities are to bring more competition to the market and address the high costs of medicines. Therefore, the Agency has released a series of updated guidance documents, which demonstrate the FDA’s commitment to bring high-quality, safe, effective, and affordable generic medicines to all consumers. Are you planning for an ANDA submission? Do you need an expert’s assistance for compliance? Contact Freyr – a proven Regulatory partner. Stay informed. Stay compliant.



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