What are DESI documents?

Last updated on April 28, 2020

The DESI (Drug Efficacy Study Implementation) program was setup in the 1960's by the FDA to thoroughly evaluate the efficacy and safety of drugs that were on the US market between 1938 and 1962. A panel of experts evaluated the available data, documents and literature on the drug under investigation. Next, the panel wrote a report with recommendations.

DESI documents are an excellent source of precedent data on safety and efficacy, to support new drugs development projects. Although public domain information, DESI documents are only available as scans of microfiche files, making them very hard to access and read.

A PharmaPendium subscription includes access to full text searchable DESI documents (2,769 documents/32,290 pages). This allows Pharmaceutical researchers to effectively retrieve relevant historical safety and efficacy data and ruling on drugs. This helps to make informed drug development decisions and supports regulatory affairs professionals in discussions with regulatory authorities.

The DESI documents can be searched in full text using the quick or advanced text search features in PharmaPendium. View more information on DESI documents./p>

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