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.
You may also be interested in...
The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.
FDA wants to publicize some aspects of designs accepted into pilot, which might discourage industry participation.
US FDA officials appears worried about workload created by product development and pre-submission meetings for complex generics.