Sunshine Act Hits Daylight Savings Time; PhRMA Seeks Extension For Physician Payment Reporting
Industry groups have asked HHS Secretary Kathleen Sebelius to give companies additional time to collect and report their payments to physicians and teaching hospitals since HHS has yet to establish the procedures for doing so.
Learn what's happening at the US FDA. On the go.
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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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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.’
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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.
