PDUFA Negotiations End With Differences To Resolve In Commitment Letter

The entire PDUFDA VI reauthorization process likely is more than a year from completion, but agreeing on a draft commitment letter is a major milestone for FDA and the pharma industry. It will serve as the foundation of the legislative phase expected to begin in early 2017.

Negotiations on re-authorizing the Prescription Drug User Fee Act are completed, but it appears that industry and likely FDA are continuing to vet the draft commitment letter for final approval.

Both FDA and industry agreed Jan. 29 to take the draft commitment letter and proposed statutory changes to their senior management for ratification, according to minutes of the...

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