NDA/BLA Approval Totals: Will US FDA Recover From Slow Start Again?
Since 2018, the agency usually has increased its average NDA/BLA approvals per month after April, but the data also suggest an overall downward trend in productivity.
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US FDA’s Use Of CRLs Hit A High Note In 2022: One-Third Of Novel Agent Decisions Were Not Approvals
Pink Sheet infographic details the 20 complete response letters the US FDA issued for novel agents last year.
With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals
US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.
One-Page Patient Medication Information Document Moves Forward Under Proposed Rule
After decades of work, the US FDA released proposed requirements for a simplified version of the Medication Guide for all products. Electronic distribution in lieu of paper ‘upon a patient’s request’ would be allowed. Comments sought on the value of consumer testing of the documents.