PDUFA V Commitment Letter Front-Loads Guidance, Meeting Milestones
It may not feel like it to exhausted user fee negotiators, but the release of FDA’s draft commitment letter for PDUFA V signals the start of more long campaigns for the agency and pharmaceutical companies.
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The struggles that industry and FDA face when trying to best standardize and evaluate REMS are illustrated by the dozens of topics jammed into the two-day meeting.
The agency cited the forthcoming guidance in response to an HHS Inspector General report that questions the effectiveness of the risk management program.