Elsevier adds extensive FDA Advisory Committee content to new PharmaPendium

Apr 2 2010

PharmaPendium, Elsevier announces a new release that adds extensive FDA Advisory Committee content to the online resource for authoritative preclinical, clinical and post-market drug information. These documents provide preclinical and clinical drug development and regulatory affairs departments with a substantial collection of comparative scientific and regulatory data that may not be included in final FDA Approval Package documents. For the first time FDA Advisory Committee content and FDA Approval Packages can be searched simultaneously via a single source on PharmaPendium.

"The addition of FDA Advisory Committee content, one of our top priorities in response to user demand, gives preclinical safety and regulatory affairs access in a searchable format to data that may not be included in final FDA approval documents. It affords a valuable window into the FDA approval process," commented Philip MacLaughlin, Senior Product Manager at Elsevier. "It supports the analysis and leveraging of regulatory precedent and experimental data so that companies can speed the approval process, avoid regulatory cycling and learn from the experience of others."

This expansion of searchable FDA approval coverage gives pharmaceutical and biotechnology companies deeper insights into regulatory context, precedent content and the FDA drug approval process. Organized by committee, more than 140,000 pages of FDA Advisory Committee meeting minutes, rosters, supplementary documents, transcripts and PowerPoints are being added. Content from 19 CDER and CBER committees is represented.

PharmaPendium is designed to support both scientific and business decisions within the pharma/biotech industry.

Source: Elsevie