Pacira believes new clinical trial of post-surgical pain medication will satisfy FDA concerns raised in complete response letter for its supplemental NDA.
Three years after receiving a "complete response letter" for its Exparel (bupivacaine liposome injectable suspension) supplemental new drug application for use as a nerve block, Pacira Pharmaceuticals Inc. will be presenting new data to a US FDA advisory committee.
The agency announced in a Federal Register notice to be published Jan. 11 that the Anesthetic and Analgesic Drug Products...
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.
