Accutane/Generics Risk Program Should Include Mandatory Follow-Up Survey
A single centralized pregnancy risk management program for Roche's Accutane and generic isotretinoin products should include a mandatory post-treatment survey, a joint FDA advisory committee said Feb. 27
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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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