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Time for Transparency: PDUFA V’s Big “Experiment”

This article was originally published in RPM Report

Executive Summary

Industry came to the PDUFA V negotiating table with one big agenda item: improved communication with FDA officials about a product under review. They succeeded, but it came with a price: an extra two months for FDA to review an application. While it may seem like things just went back to 2002, both industry and the agency say it could actually lead to faster approvals.

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The “Program” At Half-Time: Report Finds Happy Sponsors, But Tweaks Suggested

Drug sponsors are enthusiastic about FDA’s new review “Program” for novel drug and biologic applications. But they also want to see some tweaks to make the review process even more efficient – ideas that are sure to be brought to the PDUFA VI negotiating table. One trouble spot FDA says will be addressed right away: manufacturing facility inspections for Program applications.

FDA Review “Program” Tweaks May Include Smaller Mid-Cycle Meetings

Mid-cycle meetings under FDA’s review “Program” have ballooned into 30- to 40-person affairs – far larger than originally envisioned under PDUFA V – making mid-cycle calls difficult to schedule, especially for expedited products with tight review timeframes. It is one lesson learned from the Program’s first 18 months.

FDA Review “Program” Tweaks May Include Smaller Mid-Cycle Meetings

Mid-cycle meetings under FDA’s review “Program” have ballooned into 30- to 40-person affairs – far larger than originally envisioned under PDUFA V. Those numbers – which can sometimes include the entire FDA review team – have made mid-cycle conference calls difficult to schedule, especially for expedited products with tight review timeframes. It is one lesson learned from the first 18 months of the Program.

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