Animal Efficacy Rule Will Be “Flexible” About Species Needed – CBER’s Zoon
FDA will exercise more flexibility in the number of animal species required for testing before approval of counter-terrorism products under the final animal efficacy rule, Center for Biologics Evaluation & Research Director Kathy Zoon, PhD, said
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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.
