In podcast interview, US FDA’s Center for Drug Evaluation & Research Director Janet Woodcock discusses her plans the Office of New Drugs, including changes to the structure of the office to make reviews better managed and more uniform across divisions. Woodcock says she expects to stay in the interim OND role for most of 2017.
US FDA’s Center for Drug Evaluation & Research Director Janet Woodcock, MD, will spend at least the next six months as acting head of the Office of New Drugs to implement policy and structural changes to the review process for new drugs and biologics.
Woodcock took over the office as acting director – rather than promoting someone from within the agency – after the...
<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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