While arguing that US FDA overestimated inflation and fill rates when calculating annual cost of co-prescribing naloxone with opioids, Adapt Pharma opened door to pricing pledge questions that the Narcan sponsor could not answer.
Naloxone manufacturers strongly disputed the US FDA's estimate of cost increases associated with co-prescribing the rescue medication with an opioid as vastly overstated, but could not diffuse advisory committee concerns.
The agency also lured Adapt Pharma Ltd./Emergent BioSolutions Inc. into a classic drug pricing trap by forcing a...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
