Behind-The-Counter Guidance Stalled, But Interest Grows To Expand Access
FDA executives say behind-the-counter status for nonprescription drugs resonates in discussions at the agency, but a former deputy commissioner says the agency's BTC interests are stifled by not having explicit authority
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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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.
