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Thursday, October 02, 2008
FDA Offers Advice on End of Phase IIa Meetings
The FDA is recommending that IND sponsors meet with the agency at the end of Phase IIa clinical trials to discuss dose estimation and selection for late-stage efficacy trials and whether novel trial designs would be useful, according to a new CDER draft guidance. The meeting also would allow sponsors to discuss critical data on drug interactions, studies in special populations defined by genetic characteristics or other biomarkers, and other pharmacokinetic or pharmacodynamic relationships.
The FDA is also recommending that IND sponsors meet with the agency at the end of Phase IIa clinical trials to discuss dose estimation and selection for late-stage efficacy trials and whether novel trial designs would be useful, according to a draft guidance from the Center for Drug Evaluation and Research.
Comments on the draft are due Nov. 25.
Edited on: Thursday, October 02, 2008 2:06 PM
Categories: guidelines