PDUFA VII’s Big Commitments: ‘Goal Inflation’ Accelerates
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.
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If they reach a public disclosure agreement, a handful of sponsors will be admitted to a new pilot program that allows four meetings with the FDA on rare disease endpoint issues.
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.
CDER Hiring Is Booming: Flexibility Of Remote Work During Pandemic Helps Drive Numbers, Cavazzoni Says
Employment totals have also been aided by a (surprisingly) low attrition rate during the pandemic and CDER’s full use the ‘Cures’ authorities; 20% of CDER’s workforce has been hired under Cures.