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Pivotal Studies in Three Formats

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If a new drug or biologic is approved by the United States Food and Drug Administration (FDA), the pivotal studies that appeared in the FDA Advisory Committee Briefing Information often appear again in the Medical Review(s) and Statistical Review(s) sections of the FDA Approval Package for the drug. There may be differences in the information due to different reviewer analyses.

Some of the pivotal studies, although not all, are also published in journals. Therefore, it is sometimes possible to find 3 different write ups or reviews of the data from a pivotal study.
    
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  IDIS Drug Database 1966 - July 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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