Requests for meetings with FDA staff about products in development should include pertinent details about pediatric study plans, human factors engineering plans and combination product information; new guidance documents on formal meetings under PDUFA VI and communications with IND sponsors operationalize user fee program commitments and will promote earlier, more thorough engagement, agency says.
The US FDA wants sponsors to provide more information about drugs under development when they request a formal meeting with the agency pursuant to the Prescription Drug User Fee Act (PDUFA VI).
Requests for Type A, B or C meetings should now include information, if applicable, about pediatric study plans, human factors...
<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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