PDUFA VII negotiations wind up; CMC, IT modernization issues resolved

Regulatory NewsRegulatory News | 23 March 2021 |  By 

Negotiations between industry and the US Food and Drug Administration (FDA) for the sixth reauthorization of the prescription drug user fee program (PDUFA VII) have concluded after another round of subgroup meetings.
The most recent subgroup meetings focused on edits and updates to draft commitment language. In the 3 February FDA and industry manufacturing meeting, for example, the minutes reveal that “Both parties reviewed each draft commitment line by line and discussed any concerns in real time.” Updates coming from this meeting resulted in adding more context about four-part harmony principles to product quality information requests.
The manufacturing subgroup also reviewed commitment language addressing enhancing inspection communication as it relates to applications, and went over eligibility for the chemistry, manufacturing and controls readiness pilot. Industry and FDA also spent time discussing what pilot application information would be publicly disclosed.
This subgroup meeting ended with an agreement to finalize any further commitment language edits by email.
The digital health technology/data and information technology modernization subgroup also came to agreement on issues that it had been dealing with, finalizing its draft commitment language as well. On 1 February, attendees of the virtual subgroup meeting agreed that industry would provide input at an annual joint meeting and FDA would report its modernization milestones as strategy evolves.
Both parties agreed that key stakeholders should participate in the process of moving forward with modernization, with industry advocating for “technology convergence across FDA centers.”
On 26 January, the last meeting for which minutes are available for the Center for Biologics Evaluation and Research (CBER) breakout subgroup, the minutes note that progress was made on commitment language for proposals related to cell and gene therapy, with “additional refining of the commitment language” to occur “as needed.”
Progress also continues in negotiations for reauthorization of the Generic Drug User Fee Amendments (GDUFA III). A 25 February meeting addressed inspection proposal details, after tackling enhancements to the Inactive Ingredient Database, among other issues, the previous week. Parties in the GDUFA III negotiations continue to grapple with how to handle business days when calendar date-based goal dates are set.


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