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FDA Taking Comments on BsUFA II Review Assessment Project

June 30, 2017

For the next generation of the FDA’s biosimilar user fee program, the agency is proposing a new model for reviewing 351(k) applications — allowing for additional communication between review teams and sponsors through development meetings across the submission timeline.

To accommodate the increased interaction, the FDA said its review clock will begin after a 60-day administrative filing review period. The ultimate goal is to improve the effectiveness of first-cycle reviews, by giving applicants the opportunity to clarify previous submissions and provide additional data and analyses, the agency said.

Ahead of the launch of BsUFA II slated to take effect in October — pending action from Congress this summer — the FDA has opened a public comment docket regarding an assessment of the increased communications program, to be conducted by an independent contractor. The evaluation is required as part of the agency’s performance commitments in the proposed user fee reauthorization.

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