First quarterly report of median US generic drug times shows longer time to approval than previous estimates, but that may not tell stakeholders much.
The US FDA is reporting median and mean ANDA approval times quarterly as part of GDUFA II, but the data may not offer much help for stakeholders tracking agency performance.
The report suggests ANDA approval times continue to slow, despite more than five years working under the generic drug user...
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Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.
The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.
The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.
In line with new President Lee’s campaign pledges, South Korea's newly confirmed health minister is expected to tackle key issues including a prolonged doctors' conflict, essential drug supplies and R&D support for the industry.
The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.
The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.
