Breakthrough Products Should Be Free Of PDUFA Constraints, Sponsors Say
The types of FDA/sponsor interactions and timelines for meetings should not be limited by the user fee measure, industry commenters say in response to FDA’s draft guidance on expedited pathways. Some patient advocacy groups urge FDA to reconsider plans for withdrawing breakthrough designation in certain situations.
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New communication mechanisms built into the Prescription Drug User Fee Act V agreement are unlikely to be the panacea for the regulatory, economic and public relations challenges created when a small company attempts to bring its first drug to market.
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.
Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.