OTC "Actual Use Studies" Subject To Financial Disclosure Requirements
This article was originally published in The Tan Sheet
Executive Summary
"Actual use studies" conducted in support of Rx-to-OTC switch or direct-to-OTC new drug applications and used to show effectiveness in the OTC setting are subject to FDA's financial disclosure requirements, according to a draft guidance clarifying the agency's February 1998 final rule.You may also be interested in...
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Conflict of Interest Waiver Details For Cmte. Members Should Be Public – BMS
FDA advisory committee members granted conflict of interest waivers should be required to disclose the companies to which they have financial ties, Bristol-Myers Squibb maintains in comments to FDA
Conflict of Interest Waiver Details For Cmte. Members Should Be Public – BMS
FDA advisory committee members granted conflict of interest waivers should be required to disclose the companies to which they have financial ties, Bristol-Myers Squibb maintains in comments to FDA
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