Pregnancy Adverse Events Could Be Shown Separately Under Labeling Reform
Pregnancy-related labeling reforms could include displaying birth defect incidence information in a separate section from general adverse events, Center for Drug Evaluation & Research Office of New Drugs Pregnancy Labeling Team Leader Kathleen Uhl, MD, suggested
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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.
