News and highlights of applications submitted for US FDA approval, from the Pink Sheet’s FDA Performance Tracker
The first weeks of March brought in a flurry of new drug applications to the US Food and Drug Administration, including two new molecular entities from big pharma stalwart Merck & Co., Inc.. Towards the other end of the size spectrum, Reata Pharmaceuticals, Inc. and On Target Laboratories LLC each submitted their first novel candidates.
BioXcel Therapeutics, Inc. stood out with two announcements for its orally dissolving film formulation of an established IV sedation...
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.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
