Regulatory Trackers
Global Pharma Guidance Update
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.
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.
Comprehensively track regulatory guidance documents issued by medicines authorities from around the globe. Updated monthly.
EMA Tools & Trackers
Decisions on sponsor requests for accelerated assessment of planned EU marketing authorization applications that will be reviewed by the European Medicines Agency’s human medicines committee (the CHMP) as well as information on whether MAAs granted accelerated assessment retain fast-track status as they make their way through the EU centralized procedure. Updated monthly.
Products containing new active substances that have been approved for marketing in the EU under the EU’s centralized authorization procedure. Updated monthly.
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.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
FDA Tools & Trackers
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.