FDA Approval Packages Provide Access to Unbiased Reviews of Published and Unpublished Studies

There is a growing body of evidence which suggests that reporting of clinical trial results is biased (Publication Bias Found Among Trials Submitted To FDA: New Study). One recent study concluded that more than 50% of all trials submitted to the FDA during the drug approval process remain unpublished five years after the drugs are approved (Half Of Trials Supporting FDA Applications Go Unpublished).

With IDIS, you have access to the entire FDA Approval Package for a particular drug, so you can read about all the trials reviewed by the FDA for a particular drug, not just the ones that have been published.

FDA Approval Packages contain the research information on new drugs or biologics submitted to the FDA by drug sponsors that has been analyzed and critiqued by experts at the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). Once a new drug or biologic is approved for marketing, the FDA is required to make the Approval Package available to the public.

Approval Packages are typically large, unwieldy documents ranging from 50 to 1500 pages. To make these documents manageable, we prepare a Table of Contents and identify the pivotal studies for each package. These are the studies the drug sponsors believe prove the efficacy and safety of their submitted drug or biologic.

Drug Approval Packages available in IDIS for drugs approved in 2008 include those for Cimzia, Cinryze, Durezol, Entereg, Intelence, Lexiscan, Relistor, and Treanda. To search for these in IDIS, enter the drug name in Title field, and use Descriptor 155 - FDA Approval Package. New Approval Packages are continually added to the IDIS database.