FDA's Drug Promotion Advisory Reviews Taking Longer
FDA is having trouble meeting its internal goal of 45-day reviews for core launch materials due to complex issues that have required medical review division consultations, Office of Prescription Drug Promotion Director Abrams says.
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Off-Label Communication: Pfizer Highlights Burdens Of FDA Policy
Seeking relaxation of US agency restrictions, Pfizer cites three examples where company delayed or decided against distributing medically relevant information beyond the product labeling; PhRMA survey shows almost half of all requests for information by prescribers and payers relate to off-label use.
Remoxy's Woes Stoke Criticism Of FDA's Review Of Abuse-Deterrent Opioids
FDA's complete response letter includes extensive list of new studies needed to support abuse-deterrence claims not featured in two prior CRLs, Pain Therapeutics says, wondering why the agency is only now raising issues that could have been discussed previously.
FDA's Decline In Promotion Enforcement Highlighted By Celator Booth Letter
FDA's Office of Prescription Drug Promotion issues only its third letter of 2016, although it hopes to cast wide net by targeting high-profile events like ASCO.