PDUFA Negotiations End, Approval Process Ongoing
This article was originally published in The Pink Sheet Daily
Industry still working on ratifying draft commitment letter.
You may also be interested in...
Generic User Fee Talks Reach 'Final Wording' But Still Not Done
FDA and industry say they have reached tentative agreement, but finance subgroup says more discussion needed.
Sponsors, FDA Reviewers To Get More Flexibility Under New User Fee Program
Next iteration of PDUFA will feature new communication plans that allow FDA and sponsors to drop mid-review meetings if desired.
FDA Meets ANDA Backlog Goal Early, Still Doesn't Feel Out Of Woods
Office of Generic Drugs reviewed more than 90% of official GDUFA backlog of pending applications, but many still will require more work.