Capacity adjustments, DMFs under discussion for GDUFA III

Regulatory NewsRegulatory News | 12 May 2021 |  By 

Newly released minutes show progress made during the past two months of negotiations between the US Food and Drug Administration and industry on commitment language for the second reauthorization of the Generic Drug User Fee Amendments (GDUFA III).
In March and April, FDA and industry focused on a number of ongoing issues in seven negotiation meetings. (RELATED: Industry-FDA GDUFA III negotiations seek higher first-round approval rates, Regulatory Focus 11 November 2020)
FDA’s efforts to build capacity to meet increased demands include modernization of its time reporting approach and developing resource capacity planning adjustment (CPA) capabilities. Commitments were made under the last round of user fee programs to develop these capabilities, with the aim that “FDA will build more systematic, data-driven, and repeatable processes to better understand and anticipate its current and future resource demands,” according to the FDA website. “This will enable the agency to more proactively ensure its organizational components are optimally resourced.”
The consulting firm Booz Allen Hamilton conducted an independent evaluation of the methodology for the GDUFA resource capacity planning adjustment. In its report, the firm found that FDA’s proposed methodology could “accurately assess resource demand” for the GDUFA program. “Overall, FDA’s proposed CPA methodology would align with the objective to develop a methodology that accounts for the sustained increases in the GDUFA program resource needs to perform reviews,” according to the report, which makes some additional recommendations to increase the efficiency and effectiveness of the proposed CPA program.
FDA, in the 8 April meeting, presented clarifying information to industry about how the CPA would work within GDUFA III.
On 22 April, FDA “presented a final set of slides clarifying the proposals for setting a sound foundation for maintaining programmatic success and continued clarifying proposals around inspections and streamlining annual reporting requirements,” according to the minutes.
At this meeting, FDA and industry reached agreement that they would not proceed with a site engagement program that had earlier been on the table; the Inactive Ingredient Database was also a topic of discussion.
Looking at details of inspection proposals at the 11 March meeting, FDA and industry discussed whether business days should be taken into account when setting certain goal dates for responses. “The goal dates will continue to be in calendar days,” according to the minutes from that date.
A mid-April meeting touched on the approval of complex products, a topic discussed previously. At this 15 April meeting, industry came forward with a new set of proposals designed to increase earlier approvals of complex generics.
Another topic discussed in several meetings through the spring was finding a way to streamline the annual reporting commitments for drug master files (DMFs). On 25 March, industry and FDA spent some time working through potential outreach regarding what factors should go into the timing of unsolicited DMF amendments.
In the process of streamlining reporting for annual commitments, FDA’s proposals attempted to maintain “key and meaningful categories of interest for Industry,” according to the 25 March minutes.
On that same date, negotiations also turned to how inspections contribute to meeting requirements for a complete review under GDUFA, and how the travel restrictions of the pandemic are currently affecting how those requirements are met. “A complete review is required to meet a goal date,” noted the 25 March minutes.
GDUFA III Reauthorization Negotiation Sessions


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Tags: FDA, GDUFA, generics, US

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