FDA updates guidances to clarify new generic drug meeting requirements in GDUFA III

Regulatory NewsRegulatory News | 05 October 2022 |  By 

The US Food and Drug Administration (FDA) has updated four guidances to address new commitments made in the latest Generic Drug User Fee Amendments (GDUFA III) program. The guidances revise ones issued under GDUFA II and clarify how the agency plans to hold up its end of the new user fee deal, which covers FY 2023 to FY 2017.
 
FDA updated a 2020 guidance on how it designates products as competitive generic therapies (CGT) to expedite certain generic products to market. The updated guidance outlines expectations for abbreviated new drug applications that receive CGT designation which qualify them for mid-cycle review meetings (MCRM) and enhanced mid-cycle review meetings (EMCRM).
 
“Applicants of an ANDA for a drug product designated as a CGT may be eligible to request a mid-cycle review meeting (MCRM) during the first assessment cycle,” FDA states. “Applicants of an ANDA for a complex product (including complex drug products designated as a CGT) may be eligible to request an enhanced mid-cycle review meeting (EMCRM).”
 
The agency notes MRMs give sponsors an opportunity to ask FDA to provide a rational for any deficiencies identified in mid-cycle discipline review letters (DRL) and ask about FDA’s assessment of the data in the ANDA application. However, the agency also notes that sponsors are not allowed to present any new information at the meetings.
 
If a sponsor asks for an MCRM and FDA grants it, the agency plans to convene the meeting within 30 days of the sponsor’s request.
 
FDA also updated another guidance on post-complete response letter (CRL) meetings between the agency and ANDA applicants based on commitments it made to industry in GDUFA III. The revised guidance updates new performance goals agreed to in GDUFA III and clarifies how the agency plans to conduct post-CRL clarification meetings and explicitly states such meetings will be held via teleconference.
 
The performance goals are mostly the same between GDUFA II and GDUFA III. However, FDA said it plans to schedule a date for post-CRL clarification teleconferences in 90% of cases within 14 days instead of 10 days of receiving a written request in the new guidance.
 
The agency also updated its recently issued guidance on information requests and discipline review letters under GDUFA. (RELATED: FDA issues trio of guidances aimed at boosting generic competition, reducing review cycles, Regulatory Focus 26 January 2022)
 
Finally, FDA published an updated guidance on formal meetings between FDA and ANDA applicants of complex products that incorporates commitments in the latest user fee agreement. The updated guidance includes details on complex meeting types and agreed performance goals the agency need to meet between FY 2023 and FY 2027. It also includes information on how to request the complex meetings and FDA’s procedures for handling them.
 
“As described in the GDUFA III commitment letter, the pre-ANDA program includes product development meetings and pre-submission meetings and is intended to clarify regulatory expectations for prospective ANDA applicants early in product development, assist applicants in developing more complete submissions, promote a more efficient and effective ANDA assessment process, and reduce the number of assessment cycles required to obtain ANDA approval,” FDA said.
 
“The ANDA assessment meeting program for complex products includes MCRMs, EMCRMs, and post-CRL scientific meetings,” the agency added. “The ANDA assessment meeting program is intended to provide or continue to provide targeted, robust advice to ANDA applicants as they work to meet the standards for ANDA approval. Some elements of these programs are tailored to enhance the development of complex generic products.”
 
The latest guidance also includes EMCRMs and post-CRL scientific meetings based on GDUFA III.
 
FDA notes that EMCRMs are meant to provide ANDA applicants opportunity to ask questions related to a proposed scientific path to address possible deficiencies identified in the mid-cycle DRL. While sponsors can ask about potential new data or information to address potential deficiencies, the agency emphasizes it will not provide substantial assessment of the information at the meeting.
 
Similarly, the guidance states ANDA applicants can request post-CRL scientific meetings to get input from FDA on deficiencies in the CRL related to establishing equivalence. They can request the meeting even if they have not had a product development meeting with the agency yet.
 
“FDA agreed to grant the meeting if it is for a complex generic product or in FDA’s judgment the request raises issues that are best addressed via this meeting process and cannot be adequately addressed through controlled correspondence,” FDA said. “An ANDA applicant may have a post-CRL teleconference to seek clarification concerning deficiencies identified in a CRL (post-CRL clarification teleconference) prior to requesting this meeting.”

 

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