FDA Issues New Set of Guidances Focused on Generic Drug Submissions and Labeling Updates

In late January 2022, the United States Food and Drug Administration (FDA) issued three guidances (two final and one revised draft) to clarify certain aspects of the generic drug submission process and labeling updates. FDA noted that the guidances support the FDA’s Drug Competition Action Plan (DCAP) to encourage “robust and timely market competition for generic drugs.”

Information Requests and Discipline Review Letters Under GDUFA Final Guidance

One of the three guidances is the final guidance, Information Requests and Discipline Review Letters Under GDUFA, which describes how the FDA issues and uses information requests (IRs) and discipline review letters (DRLs) during the assessment of an original abbreviated new drug application (ANDA).

In the guidance, the FDA iterates its commitment to providing generic drug applicants with preliminary thoughts on potential deficiencies through an IR or DRL as each assessment discipline finishes its initial assessment of its application portion. This allows applicants to resolve issues in that same assessment cycle. By reducing the number of assessment cycles needed for approval, FDA can approve more applications for safe, effective, high-quality generic drugs and increase Americans’ access to affordable medicines. The final guidance will also help to improve the predictability, transparency, and efficiency of the FDA assessment process.

This guidance does not apply to an amendment made in response to a complete response letter (CRL), a supplement, or an amendment to a supplement.

Good ANDA Submission Practices

The second guidance, Good ANDA Submission Practices, is intended to help applicants preparing to submit ANDAs to the FDA. The guidance highlights some common deficiencies that might lead to a delay in the approval of an ANDA and makes recommendations on how to avoid those deficiencies. It, similar to the above final guidance, helps the FDA’s goal of minimizing the number of review cycles before approval.

Revising ANDA Labeling Following Revision of the RLD Labeling

The third and final guidance is a revised draft guidance, Revising ANDA Labeling Following Revision of the RLD Labeling, outlines recommendations for updating labeling for ANDAs following approved revisions to the labeling of a reference listed drug (RFD), including how to monitor for RLD labeling updates and how to submit labeling updates to unapproved and approved ANDAs to conform to RLD labeling updates.

FDA expects an ANDA holder to update its labeling after the agency has approved relevant changes to the labeling for the corresponding RLD. By facilitating prompt submission of labeling changes to unapproved ANDAs to conform to RLD labeling updates, the agency expects this guidance to help ensure timelier ANDA approvals and enable patient access to generic drugs sooner.

FDA Statement

“These guidances are part of our continued efforts to 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.  Bringing more competition to the market and addressing the high costs of medicines are top agency priorities,” the agency said in a statement.