Forthcoming 'guidance on guidance,' required under 21st Century Cures Act, should explain different ways that advocacy groups can get patient experience data in front of FDA and provide an opportunity for early interactions before groups go down the guidance development route.
The US FDA's forthcoming guidelines on how external groups can develop proposed draft guidance for agency consideration should discuss other ways for submitting patient experience data short of the formal guidance route, patient advocates said.
At a March 19 meeting convened by FDA, representatives from several advocacy organizations raised concerns that the agency's forthcoming draft...
<p>Executive Summary</p> <p>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.</p>
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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