OTC Drugs Office Take Two: FDA To Elevate Division Through CDER Revamp
This article was originally published in The Pink Sheet Daily
FDA proposal for Office of OTC Drug Products would oversee two divisions for monographed, NDA-approved products. Former home of OTC division, ODE V, would be eliminated under CDER reorganization.
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Neurology and psychiatry drugs would be reviewed in separate divisions under the proposed restructuring. The reorganization, which aims to group products by therapeutic indications and integrate the review of biologics and drugs, would eliminate ODE V.
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.