As of October 2022, 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) programme. To enhance the ability to have productive discussion about prospective products, the guidances now include provision to permit and remote meetings between FDA and prospective and current abbreviated new drug application (ANDA) applicants.
Specifically, there have been updates to a 2020 guidance [1] on how FDA designates products as competitive generic therapies (CGT) which now includes provision for mid-cycle review meetings and extended mid-cycle review meetings. In addition, to expedite certain generic products to market, updates have been made to guidance on post-complete response letter (CRL) meetings [2] between FDA and ANDA applicants, noting that any meetings should take place via teleconference. There were also updates on the guidance on information requests and discipline review letters under GDUFA [3]. And finally, FDA published an updated guidance on formal meetings between FDA and ANDA applicants of complex products [4] that incorporates commitments made in the latest user fee agreement.
The final updated guidance [5] includes details on all complex meeting types and agreed performance goals the agency needs to meet between fiscal year 2023 and 2027. The following meeting types are included: product development meetings, pre-submission meetings, mid-cycle review meetings, enhanced mid-cycle review meetings, and post-complete response letter scientific meetings; that all take place between ANDA applicants and FDA. It also includes information on how to request the complex meetings and FDA’s procedures for handling them.
The mid-cycle review meetings (and enhanced mid-cycle review meetings) are specifically relevant to products designated as competitive generic therapies (CGT). These products may be granted 180 days marketing exclusivity if they are the first approved applicant for that CGT and meet certain other conditions [6]. The CGT programme was designed to encourage the development and marketing of generic drugs for products with little to no competition [6]. CGT ANDA applicants will now be able to request mid-cycle review meetings and 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. If requested, such a meeting should take place within 30 days. However, it is noted that no new information can be presented at such meetings.
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References
1. U.S. Food and Drug Administration. Competitive generic therapies. Guidance for industry. October 2022 [homepage on the Internet]. [cited 2022 Dec 1]. Available from: https://www.fda.gov/media/136063/download
2. U.S. Food and Drug Administration. Post-complete Response Letter clarification teleconferences between FDA and ANDA applicants under GDUFA. Guidance for industry. October 2022 [homepage on the Internet]. [cited 2022 Dec 1]. Available from: https://www.fda.gov/media/108337/download
3. U.S. Food and Drug Administration. Information requests and discipline review letters under GDUFA. Guidance for industry. October 2022 [homepage on the Internet]. [cited 2022 Dec 1]. Available from: https://www.fda.gov/media/109915/download
4. U.S. Food and Drug Administration. Formal meetings between FDA and ANDA applicants of complex products under GDUFA. October 2022 [homepage on the Internet]. [cited 2022 Dec 1]. Available from: https://www.fda.gov/media/107626/download
5. GaBI Online - Generics and Biosimilars Initiative. US brand-name drug market exclusivity periods remain relatively unchanged over the past decade [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 1]. Available from: www.gabionline.net/generics/research/us-brand-name-drug-market-exclusivity-periods-remain-relatively-unchanged-over-the-past-decade
6. GaBI Online - Generics and Biosimilars Initiative. FDA reaches 100 generics approvals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 1]. Available from: www.gabionline.net/generics/general/fda-reaches-100-generics-approvals
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