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Drug and Biological Approval Reports
Listing of approved New Drug Applications (NDAs), Biological Licensing Applications (BLAs), New Molecular Entity Drugs (NMEs), and New Biologics. Also includes statistics on approval times and approval rates. See What's New at CDER?
for the most recent approvals.
Search by drug name, active ingredient, or application number to receive a drug details report including therapeutic equivalents and approval history
European Medicines Agency (EMEA)
European drug regulatory agency.
FDA Center for Drug Evaluation and Research (CDER)
U.S. Agency involved in new drug development and review, generic drug review, over-the-counter drug review, and post drug approval activities.
Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchaneability Evauatios
The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act)
Use BI PHRM DEX to look for drugs by name, indication or mechanism of action.
Cortellis' Company & Drug Pipeline Reports are available via Thomson One. Select Screening & Analysis--> Research --> Research Search. Search by cortellis as a contributor to locate these reports. Note: This resource only works with Internet Explorer
R&D Focus Drug News (published by IQVIA) is a source for IND and NDA announcements. To search for these items, navigate to Search -- Search Builder and try the following:
rst=(rdfn) and ((ind or investigational or nda or new drug) near10 (file* or submi* or appli*)). FDANews Drug Daily Bulletin is another publication that tracks this type of information: search for rst=fdadb.
Covers several publications that track news about drug approvals. To search these items, type the desired source into the main search bar, for example, Scrip's Pink Sheet. Locate the source on the auto-populated dropdown list of sources that appears, and click the magnifying glass+ button to add the source to your search.
Listing of clinical studies sponsored by the National Institutes of Health (NIH) and other federal agencies, private industry, and nonprofit organizations.
International Clinical Trials Registry Platform
Sponsored by the World Health Organization. This aggregator site pulls trial information from other registries, e.g metaRegister of Controlled Trials, Chinese Clinical Trials Register, etc.
Register of Controlled Trials
Search across UK-sponsored trials, as well as US-sponsored trials pulled from Clinicaltrials.gov.