FDA is again relying on sponsor self-reporting as it launches GDUFA II.
FDA again will by relying on industry prior to GDUFA II's launch to ensure new user fees are correct. In this case, it's the ANDA holder fee, which was created for the reauthorization of the Generic Drug User Fee Act in part to provide a break for small businesses. It is based on the number of approved ANDAs a sponsor and its affiliates own.
To ensure FDA has the most accurate information on ANDA owners and their affiliates, the agency plans to publish its...
<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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