All FDA/CDER/FOI archived FDA drug approval review and correspondence documentation since 1938, as well as an EMEA EPAR document database, PharmaPendium offers you unrivalled insights into the entire history of drug development.

PharmaPendium includes the following content sources:

• FDA Approval Packages – allowing you to search through more than 1,3500,000 pages of information and experimental data including reviews, labels and other data.
• European Medicines Agency's (EMEA) European Public Assessment Reports (EPARs) - 80,000 pages of searchable EPAR documents on EMEA-approved drugs, including over 50 drugs/mixtures not approved by the FDA.
• Adverse Event Reporting System (AERS).
• Meyler's Side Effects of Drugs, 15th edition with over 40,000 references.
• Extracted metabolite data from literature.
• Extracted pre-clinical and clinical toxicity data.
• Extracted toxicity data from literature, from a pool of over 3,000 journals and other global sources.
• Target information.

And with FDA Classic Collection, FDA FOI drug approval documents prior to 1992 are now indexed and fully searchable.

The addition of the FDA classic collection means that PharmaPendium now has complete coverage of approved drugs since records began, so you don’t miss a thing. And for the first time in over 50 years you can scour the available biology and chemistry data on these older drugs.

EMEA

The only online source for all FDA documentation, PharmaPendium also offers you access to the European Medicines Agency’s (EMEA) European Public Assessment Reports (EPARs).

Covering approximately 80,000 pages of searchable documents for EMEA approved drugs from 1995 to the present day, and more than 300 ac­tive ingredients approved for the European market - some not approved in US - PharmaPendium is the definitive source of drug information.

The EMEA EPAR documents provide critical data on:

• Efficacy
• Indications and dosage
• Safety
• Pharmacokinetics
• Pharmacology and mode of action
• Preclinical and clinical toxicity (extracted from documents) Adverse effects (extracted from documents)
• General product information Providing real insights into the differences between the USFDA and EMEA decision making process, you can rest assured that you’re as informed as possible.