CBER director says agency understands 'we simply can't be boosting people as frequently as we are,' but wants to give older and immunocompromised individuals extra protection now while FDA considers whether and when formulations should be modified ahead of an expected surge this fall.
The US Food and Drug Administration’s recent authorization of a second COVID-19 vaccine booster dose in certain populations was a “stopgap measure” until plans are in place for a potentially new formulation ahead of an expected case surge next winter, Center for Biologics Evaluation and Research director Peter Marks said.
On 29 March, the FDA authorized a second booster of the Pfizer Inc./BioNTech SE and Moderna, Inc.'s...
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.
