[January 26, 2022] This week, FDA published a series of guidances focused on generic drug application submissions, labeling, and review. 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.
 
These guidances support FDA’s Drug Competition Action Plan (DCAP), which encourages robust and timely market competition for generic drugs. Offering clarified, up-to-date guidance for industry demonstrates FDA’s commitment to bringing more high-quality, safe, effective, and affordable generic medicines to all consumers. 

This week’s published guidances include:

Information Requests and Discipline Review Letters Under GDUFA Final Guidance 

FDA first issued Information Requests and Discipline Review Letters Under GDUFA as a draft guidance in 2017. The final guidance 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). 

We are committed to providing generic drug applicants with preliminary thoughts on possible deficiencies through an IR or DRL as each assessment discipline finishes its initial assessment of its application portion. When applicants receive our feedback around the mid-point of the review period, they have the opportunity to resolve issues in that same assessment cycle. IRs and DRLs as described in this guidance will improve the predictability, transparency, and efficiency of FDA’s assessment process. 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 also revised the accompanying Manual of Policies and Procedures (MAPP 5220.5), 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 industry.  

Revising ANDA Labeling Following Revision of the RLD Labeling Revised Draft Guidance

FDA’s draft guidance for industry, Revising ANDA Labeling Following Revision of the RLD Labeling, provides recommendations for updating labeling for ANDAs following approved revisions to the labeling of a reference listed drug (RLD), including 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. The agency first issued this draft guidance in April 2000 and has updated it with details on obtaining information on RLD labeling changes and submitting revised ANDA labeling to FDA, consistent with Generic Drug User Fee Amendments (GDUFA) procedures.

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 more timely ANDA approvals and enable patient access to generic drugs sooner.

Good ANDA Submission Practices Final Guidance

The agency first issued the guidance for industry, Good ANDA Submission Practices, in 2018. It highlights common, recurring deficiencies in ANDAs that may lead to approval delays. The 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.

Multiple review cycles are highly inefficient, require significant resources from applicants and FDA, and delay patient access to more affordable generic drugs. By providing recommendations to applicants on how to avoid these common deficiencies, this guidance will help applicants submit high-quality, complete applications the agency can approve in the first review cycle. 

Learn more about DCAP and FDA's efforts to enhance generic market competition and improve consumer drug access.