US FDA Beats Clock On NDAC Charter Renewal
Give agency credit for beating the expiration date after missing it in previous renewals.
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Survey of advisory committee members finds many believe an overwhelmingly negative vote should prevent a product approval. Survey was prompted by FDA accelerated approval of Alzheimer’s disease treatment Aduhelm despite overwhelming committee rejection.
Changes for supporting OTC labeling for drugs currently available Rx-only and indicated for chronic, more complicated conditions, aren’t minor and won’t happen within limits of one-dimensional text media printed on OTC drug containers, packages and inserts.
Consultant Susan Levy points out Alcon’s Pataday eye drops and GSK's Voltaren Arthritis Relief as examples of effective switch advertising, marketing and management. Pfizer’s Advil line has been available far longer but also is an example of effective nonprescription brand management.