FDA Must Have Compelling Reason To Deny Advisory Review Request- PhRMA
FDA must present a compelling argument for denial of a sponsor's request for an advisory committee review of an unresolved scientific dispute with the agency, the Pharmaceutical Research & Manufacturers of America said in comments on FDA's draft guidance for formal dispute resolution.
You may also be interested in...
Industry continues to exercise informal appeals rather than official dispute resolution procedures to address disagreements with FDA, Center for Drug Evaluation & Research Ombudsman Jim Morrison said.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011