PDUFA Negotiations End, Approval Process Ongoing
This article was originally published in The Pink Sheet Daily
Industry still working on ratifying draft commitment letter.
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FDA and industry say they have reached tentative agreement, but finance subgroup says more discussion needed.
Next iteration of PDUFA will feature new communication plans that allow FDA and sponsors to drop mid-review meetings if desired.
Office of Generic Drugs reviewed more than 90% of official GDUFA backlog of pending applications, but many still will require more work.