Time For Companion Diagnostics Guidance From FDA Is Now, PMC Says
Industry groups, representing drug makers, test manufacturers, labs and others, are redoubling the pressure on FDA to clarify the regulatory requirements for co-development of diagnostics and drug treatments
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.
