Accelerated Approval May Support Smaller Trials In Acute Diseases – FDA
Final guidance on expedited regulatory pathways suggests FDA is open to accelerated approval for some acute conditions; agency also provides examples outside of HIV/cancer arena where surrogate and intermediate clinical endpoints have supported approval.
You may also be interested in...
FDA should write more about its interpretation of regs and apply it more consistently across divisions, commissioner says.
Letter being circulated by Rep. Bilirakis states the agency’s draft expedited approval guidance does not provide clarity for rare disease sponsors to use accelerated approval.
Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.