FDA issues trio of guidances aimed at boosting generic competition, reducing review cycles

Regulatory NewsRegulatory News | 26 January 2022 |  By 

The US Food and Drug Administration (FDA) on Wednesday issued three guidances – two final and one revised draft – aimed at clarifying aspects of generic drug submissions and labeling updates.
FDA said the guidances support its Drug Competition Action Plan (DCAP), which was first announced in 2017. (RELATED: Gottlieb looks to boost generic drug competition, Regulatory Focus 21 January 2017)
“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 released alongside the guidances.
Final guidance: Good submission practices, IRs and DRLs
Both final guidances are aimed at reducing the number of review cycles an abbreviated new drug application (ANDA) undergoes, targeting different stages of the submission and assessment process.
The first of the two guidances FDA offers insights on preparing and submitting high-quality abbreviated new drug applications (ANDAs) to help sponsors avoid “recurring deficiencies” that could delay the approval of a generic drug.
The guidance finalizes a draft issued in 2018 and contains revisions to clarify recommendations regarding patent and exclusivity deficiencies, drug substance quality deficiencies and on using bioequivalence methods that differ from those made in a relevant product-specific guidance. (RELATED: FDA targets multiple review cycles with new draft guidance, MAPP, Regulatory Focus 3 January 2018)
The other final guidance provides an overview of how information requests (IRs) and discipline review letters (DRLs) are used during the review of original abbreviated new drug applications (ANDAs).
The guidance finalizes a draft document released for comment in 2017 and includes minor revisions in terminology. FDA also revised its internal manual of policies and procedures (MAPP) related to IRs and DRLs. (RELATED: FDA to begin issuing deficiency review letters to generic drugmakers, Regulatory Focus 15 December 2017)
The two types of letters are intended to provide applicants with feedback about potential deficiencies in their submissions around the mid-point of the review period, with the goal of providing ANDA sponsors the opportunity to address any issues during the same review cycle, thus reducing the number of assessment cycles an application might otherwise undergo.
“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,” FDA writes.
Revised guidance on ANDA labeling
FDA also released a revised draft guidance aimed at clarifying the process for submitting labeling updates for both approved and unapproved ANDAs when the labeling for the reference listed drug (RLD) is updated.
The draft guidance revises an earlier version issued more than two decades ago, long before the first iteration of the Generic Drug User Fee Amendments (GDUFA I).
FDA said the revised document now includes details about “obtaining information on RLD labeling changes and submitting revised ANDA labeling to FDA, consistent with Generic Drug User Fee Amendments (GDUFA) procedures.”
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments
Good ANDA Submission Practices Guidance for Industry
Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry


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