HHS “Unified Agenda” Shows FDA Is Behind On OTC Actions
This article was originally published in The Pink Sheet Daily
More than half of OTC drug and dietary supplement action items in the FDA regulatory agenda are holdovers from the first half of the year. FDA intends to complete 15 OTC-related actions in the second half of the year.
You may also be interested in...
Panel review provides examples of different attitudes toward switches between OTC experts, other category-specific prescribers.
Downey says Rx sales of approximately $20 mil. have restricted availability of the emergency contraceptive at pharmacies across the country.
Topical corticosteroid HPA axis suppression risk under "maximal use conditions" should preclude the OTC marketing of the dermatologic products, FDA advisory committees say. Test for hypothalamus, pituitary, adrenal axis suppression is only 70% accurate, committee members note.