Panel Continues To Push For Obesity CV Guidance As It Backs Contrave Approval
FDA signaled during an advisory committee on Orexigen's weight-loss drug Contrave that it could be ready to revise its obesity drug draft guidance, particularly with regard to cardiovascular goals, but stressed that for now, the drugs under review are to be judged by standards articulated in the draft document.
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It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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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.
