IDIS Tips and News

Pivotal Studies and FDA Advisory Committee Meetings

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The purpose of many FDA Advisory Committee meetings is to discuss the safety and efficacy of new drugs that are under review by the FDA for approval. Before an FDA Advisory Committee meeting, the Drug Sponsor and the FDA provide Briefing Information on the proposed new drug. The pivotal studies, the studies the drug sponsor believe prove the safety and efficacy of their product are very often contained in the Briefing Information from the Drug Sponsor and the Briefing Information from the FDA. Documents related to FDA Advisory Committee meetings, including the Briefing Information, may be found in IDIS by using descriptor FDA ADVISORY COMMITTEE 164 in conjunction with a drug term or other search terms. Note that not all drugs submitted to the FDA for approval are discussed at an FDA Advisory Committee meeting.
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  IDIS Drug Database 1966 - October 2014

Learn about IDIS 4.0 Drug Database by reading New Features or viewing this video.

Full-text articles/reports from 1988 through the current month are available in IDIS Drug Database.

IDIS is a database of index records to articles about drugs and drug therapy in humans taken from over 200 leading medical and pharmaceutical journals, FDA approval packages, FDA Advisory Committee briefing documents, FDA boxed warnings, AHRQ publications, National Institute for Health and Clinical Excellence (NICE) guidelines and appraisals, clinical practice guidelines and more. The complete article/report is also available online (1988 through the current month). The system is designed to retrieve specific information concerning a drug and/or drug treatment of a disease state. Authoritative publications have been selected to provide broad coverage of both general and specialty areas of pharmacy and medicine.

System Usage: Data retrieved from the database is intended for distribution solely within the subscriber's organization and may not be accessed from more than one computer concurrently without prior written permission from DDIS. The data is not to be transferred, retransmitted or used with other information for the creation of a combined or consolidated database. Under no circumstances may copies of the data be offered for sale or resale.

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