Pathways & Standards
Approval Standards
The unusual revision of Corcept’s complete response letter suggests the FDA may be writing for a different audience now that unapproved product CRLs are being made public.
Accelerated approvals of novel products rebounded in 2025 as drug development adapted to major pathway changes enacted in the FDA Omnibus Reform Act, but pending applications suggest a potentially bigger impact outside oncology in 2026.
Pink Sheet editors discuss new information on the Commissioner’s National Priority Voucher Program, including the role of the center directors and the Commissioner’s National Priority Voucher Review Council in application reviews.
The European Medicines Agency said that Sanofi’s Rezurock should be approved on a conditional basis for patients with chronic graft-versus host disease after reconsidering its initial decision not to recommend the drug.
Review Pathways
Accelerated approvals of novel products rebounded in 2025 as drug development adapted to major pathway changes enacted in the FDA Omnibus Reform Act, but pending applications suggest a potentially bigger impact outside oncology in 2026.
Pink Sheet editors discuss new information on the Commissioner’s National Priority Voucher Program, including the role of the center directors and the Commissioner’s National Priority Voucher Review Council in application reviews.
Newly revised regulations for the implementation of China’s Drug Administration Law transition to a market authorization holder/product-centered regulatory approach in response to the rapidly changing biopharma environment.
Sponsors also want efficacy supplement action packages released after redaction as part of a proposal to increase first-cycle approvals.
User Fees
Sponsors also want efficacy supplement action packages released after redaction as part of a proposal to increase first-cycle approvals.
FDA officials want to charge the generic drug program fee per ANDA owned going forward, rather than the current practice of separating firms into different fee-paying tiers based on the number of ANDAs owned.
No sponsors have been accepted into the Split Real-Time Application Review pilot program and its extension beyond 2027 appears unlikely.
The agency indicated during prescription drug user fee reauthorization discussions about performance metrics that 20% of reviewers were lost last year.