Guides: Medical Entrepreneurship: Regulation, Pipeline & Clinical Trials

Regulation

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.
Drugs@FDA
Search by drug name, active ingredient, or application number to receive a drug details report including therapeutic equivalents and approval history
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
Also includes patent and exclusivity information.
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 Related to Drugs? for the most recent approvals.
European Medicines Agency (EMEA)
European drug regulatory agency.

Bloomberg
Access details. Use BI PHRM DEX to look for drugs by name, indication or mechanism of action.
LSEG Workspace (formerly Refinitiv Workspace)
To access Cortellis Company and Pipeline Overview Reports and Cortellis Company Detailed Pipeline Reports, select Research --> Advanced Research from the main menu. In the Filters menu on the left side of the page, select a Date Range. In the Contributors field, search for and select Clarivate Analytics. Click the Search button.

NOTE: Refinitiv Workspace users may access a maximum of 150 pages of research content daily. This limit resets at 12:00 AM Eastern Time each day.

Factiva
Current and historical news from thousands of publications worldwide in over 20 languages. Company overviews and stock data are available for public companies.
Nexis Uni
Access to full-text national and international newspapers, including the New York Times, and the Times of London business and accounting information, biographical data, and some selected legal materials. News sources also include magazines, broadcast transcripts, and wire services. Among the document sources included are the U.S. Code and Federal Case Law, state codes and case law, and U.S. patents.
Note that many Congressional publications including bills and laws, the Congressional Record, the Federal Register and campaign finance and voting record data which were previously available in LEXIS/NEXIS are now accessible through Proquest Congressional.

ClinicalTrials.gov
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.
ISRCTN registry
The ISRCTN registry is a primary clinical trial registry recognised by WHO and ICMJE that accepts all clinical research studies (whether proposed, ongoing or completed), providing content validation and curation and the unique identification number necessary for publication.