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Investigational Compounds Database
The Investigational Compounds database includes compounds that have entered human testing as a “new” entity in any country by U.S firms and U.S subsidiaries since 1963. The information obtained includes development history, research activity, origins of the compounds, and foreign marketing data.
Newly Marketed Products Database
The data collected and placed in this database comprise origins of the products, clinical phase lengths, clinical holds, development and review times, regulatory review history, and marketing data for New Molecular Entities (NME) and New Biological Entities (NBE).
Biotechnology Database
The biotechnology database contains data for over 2400 investigational and marketed biopharmaceutical therapeutics, including recombinant proteins, monoclonal and polyclonal antibodies, purified proteins, synthetic peptides, and antisense nucleotides. Data for prophylactic and therapeutic vaccines are also included.
Fast Track Designation Database
Fast track designations are given by the FDA to chemical and biological products that are in development and approved. Information is collected from the public domain for these compounds and placed into this database, which is updated regularly to include the most recently designated products.
Orphan Drug Database
Drug name, sponsor, dates of designation and approval, and orphan indication information on all orphan drug designations and approvals from January 1983 to the present are recorded in this database.
EMEA Database
The EMEA database contains information on drugs that have been approved through the EMEA’s centralized procedure from 1995 (the year of the centralized procedure's inception) to present. If the EMEA-approved drug is also approved by the US FDA, the US approval information is included for comparative analysis. The database includes information on approval time, regulatory designation, novelty of compound and compound type.
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