Califf tweaks his misinformation stump speech, FDA adds to the Twitter COVID vaccine confusion with a tweet to Elon Musk, generic firms are schooled on the difference between a teleconference and a video conference, and other observations from Pink Sheet reporters’ notebooks.
Welcome to the first edition of our new feature Supplemental Filings: Pink Sheet’s Reporters’ Notebook. We’ll bring you bonus, quick-hit analysis and insights we think you should know that didn’t make it into our full-length stories. The goal is short and sweet, but just as worthy of your full approval.
US Food and Drug Administration Commissioner Robert Califf’s stump speech on misinformation evolved a little bit this week, revising the...
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.
