Company Consultant Conflict Of Interest Awareness Necessary - Ganley
This article was originally published in The Tan Sheet
Executive Summary
Sponsor companies presenting data supporting approval of new OTC drugs may not always benefit from consultant comments at advisory committee meetings due to financial conflicts of interest, according to FDA Division of OTC Drug Products Director Charles Ganley, MD.
You may also be interested in...
OTC Prilosec For Chronic Use Needs Explicit Labeling, NDAC, GDAC Advise
Chronic use of OTC Prilosec (omeprazole) may benefit patients with gastroesophageal reflux disease provided labeling explicitly lists appropriate warnings, advisory committee members concluded at a switch review for the heartburn drug.
Prilosec GERD Indication OTC Appropriateness Debated At NDAC Meeting
Gastroesophageal reflux disease is appropriate for OTC treatment, but AstraZeneca/Procter & Gamble's NDA to switch Prilosec OTC is not approvable, FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees decided at a joint meeting in Gaithersburg, Md. Oct. 20.
Pravachol Low Drug Interaction Profile Deemed Favorable During OTC Review
The drug interaction profile of Bristol-Myers Squibb's Pravachol may make the cholesterol-lowering agent a more attractive OTC switch candidate than Merck's Mevacor, FDA advisory committee members suggested.