FDA Advisory Committee Waivers Reflect Recruitment Challenges
Recent waivers allowing the participation of outside experts at drug-related advisory committee meetings reflect FDA's difficulties in finding qualified individuals to provide advice on specialized topics.
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Gastroenterology Endpoints To Get Four-Day Series Of FDA Workshops
One day each will be devoted to eosinophilic esophagitis, pediatric and adult inflammatory bowel disease, and parenteral nutrition-associated liver disease, Sept. 19, 20, 21 and 24, in that order.
FDA Gains No Impartiality Benefit From Conflict-Of-Interest Policy, Advocates Say
Friends of Cancer Research cites an FDA-sponsored study to argue that agency adherence to an advisory committee conflict-of-interest policy that is stricter than required by law does not increase the impartiality of panel members’ recommendations.
Conflict-Of-Interest Policy Relaxation For FDA Cmtes. Could Be Easy PDUFA Add-on
FDA Commissioner Margaret Hamburg’s willingness to explore changes in conflict-of-interest policies for advisory committee members, coupled with a push for reforms by industry and lawmakers, suggests a relaxation of current screening requirements could become an easy add-on to the Prescription Drug User Fee Act reauthorizing legislation in 2012.