Detailed description of advisory committees from the Code of Federal Regulations . Includes information on membership, conflict of interest, scheduling, and action on recommendations. List of Tentative Meeting Dates for Advisors and Consultants Staff . Several dates have been set aside by CDER advisory committees for possible future meetings. FDA Meeting Transcripts 1995 to Present .
Recent transcripts includes minutes, briefing information, slides and other documents.
The sponsor writes the TPI to guide the design, conduct, and analysis of clinical trials so that at the end of the development program, the sponsor will have gathered the necessary data to support the desired outcome, the approval and appropriate labeling, or package insert, of the drug under development. TPI Program Overview . Includes background information, intent of the TPI document, what the TPI document is and is not, plus a summary. TPI Template . The template provides a recommended outline for a TPI with a description of suggested information for each section.