The Real PDUFA Inflation Rate
The FDA/Industry agreement for PDUFA VI envisions a relatively modest increase in the amount of user fees paid by brand name companies; the length of the “commitment letter” outlining the agreement, however, expanded dramatically.
You may also be interested in...
Latest iteration of the Prescription Drug User Fee Act agreement negotiated by US FDA and the pharmaceutical industry continues the trend to ever larger sets of goals and commitments as part of the reauthorization process.
Stakeholders wonder about impact of placing orphan drug program staff "into review teams" as part of next iteration of user fee program.
Aggressive staffing goals for FDA’s gene and cell therapy review group might not be fully achieved – but the head of CBER believes the new organization is on track to deliver on his high expectations going forward.