FDA Crackdown On Unapproved Drugs Has Incentives For Voluntary Submissions
FDA is encouraging manufacturers of marketed but unapproved drugs to voluntarily submit applications by highlighting the possibility of a de facto exclusivity period for sponsors who receive NDA approval for a drug that other firms are marketing without approval
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.
