FDA Warning Letters Do Not Prove Wrongdoing, Appeals Court Finds
A state appeals court ruled that FDA warning letters are informal and advisory notifications and thus cannot be the basis of a finding that Johnson & Johnson made false and misleading statements to health care providers about Risperdal (risperidone) and Duragesic (fentanyl).
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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.
