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University of Washington Health Sciences Library

ITHS-WRF Fellows

Resources for drug, device, & health technology development, the FDA approval process, and health economics. (ITHS-WRF Summer Fellows)

Article Databases

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  • Biomedical literature from cell culture to patients care. 
  • Technology and therapeutics in development and in clinical use. 
  • Clinical trial reports.  Literature reviews. 
  • MeSH terms for thorough, but targeted searches, e.g. "Economics"[MeSH] or "Equipment and Supplies"[MeSH].
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  • Biomedical literature database with significant overlap with PubMed. 
  • Extracts drug and device and manufacturer names from articles.
  • "Drug development" and "pharmacoeconomics" subheadings. 
  • Emtree terms for thorough, but targeted searches, e.g. "Blood Clotting Factor 10a Inhibitor"/exp.

Standard of Care: Clinical Practice Summaries

FDA Drug Approval

How Drugs Are Developed and Approved by the FDA: Current Process and Future Directions (2014) - short article

Drugs@FDA
-- database of approval documents for FDA-approved drug products: new molecular entities, generics, and many biologics

FDA Device Approval

Medical Devices: US Medical Device Regulation (2015) - short article written by FDA authors

FDA Overview of Device Regulation - FDA website

FDA Premarket Approval - for Class III devices - FDA website

FDA Premarket Notification (510(k)) - for substantially equivalent devices - FDA website


FDA Premarket Approval (PMA) Database
--Class III medical devices approved for marketing by FDA (CDRH) based on scientific and regulatory review of safety and effectiveness. 
--Search for products by name or classification

FDA 510(k) Database
--Premarketing submissions made to FDA to demonstrate that a medical device is substantially equivalent to a legally marketed device that is NOT subject to premarket approval
--Search for products by name or classification

Health Care Reimbursement

Medicare Provider Utilization and Payment Data - from the Centers for Medicare and Medicaid Services

Current Procedural Terminology (CPT) Codes - from the Centers for Medicare and Medicaid Services

Press Releases, News, Trade Publications

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