In an interview with the Pink Sheet, implementation director Rhonda Hearns-Stewart says FDA has modified the template for its 'integrated assessment' of marketing applications in response to feedback from reviewers and sponsors.
The US Food and Drug Administration’s phased roll out of its “integrated assessment” of drug and biological license applications has gained momentum as more than 30 marketing applications have gone through the new review process and another three dozen or so are currently undergoing this assessment.
The integrated assessment differs from the standard summary review as it involves an interdisciplinary, collaborative approach to discuss key regulatory...
<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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