Mid-cycle meeting for some supplements cannot be accommodated without extending the goal date, the agency tells industry negotiators.
More user fee money cannot buy sponsors additional meetings with the US Food and Drug Administration for some application supplements.
That the message from agency officials during negotiations of the next prescription drug user fee program cycle. The FDA proposed...
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A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
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 FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.
Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
