STM publisher Elsevier, Netherlands, has announced the addition of FDA Advisory Committee content to Pharmapendium, an online resource for preclinical, clinical and post-market drug information.
The newly added documents seek to 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, according to Elsevier.
The expansion of searchable FDA approval coverage is projected to give pharmaceutical and biotechnology companies deeper insights into regulatory context, precedent content and the FDA drug approval process. Organised 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 also represented.
PharmaPendium is designed to support both scientific and business decisions within the pharma/biotech industry. The online resource seeks to provide access via a single point to searchable and trusted drug information. It covers close to 4,000 approved drugs, with integrated preclinical, clinical and post-market safety data. PharmaPendium is owned and protected by Elsevier Properties SA and used under licence.
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