Home » FDA: Provide Detailed Information in Request for End-of-Phase-IIA Meeting
FDA: Provide Detailed Information in Request for End-of-Phase-IIA Meeting
FDA meetings with sponsors at the end of Phase IIA drug clinical trials should help sponsors select dosing regimens for the next phase and design informative dose-response trials that incorporate the quantitative data the sponsor has accumulated, the agency says in a final guidance. The revised guidance clarifies the type of information the sponsor should submit with the meeting request and background package.
Drug Industry Daily
Drug Industry Daily
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