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FDA: Provide Detailed Information in Request for End-of-Phase-IIA Meeting

September 21, 2009

FDA: Provide Detailed Information in Request for End-of-Phase-IIA Meeting
FDA meetings with sponsors at the close of Phase IIA put drugs into clinical trials should help sponsors select dosing regimens for the next phase and design informative dose-response trials that incorporate the quantitative premises the sponsor has accumulated, the agency says in a final guidance. The revised guidance clarifies the type of notice the sponsor should refer with the junction desire and background package.

Written by Samanta · Filed Under FDA News