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University of Washington Health Sciences Library

Drugs and Medical Devices: Development and Regulatory Approval

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Standard of Care: Clinical Practice Summaries

These tools provide evidence-based summaries of diseases and disorders for clinicians.  They include information on incidence, prevalence, diagnosis, treatment, and complications.

Health Care Reimbursement

Market Reports, News, Trade Publications

Standards

Device Specifications

Drug Information

Scientific and Patent Publications

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Clinical Trials

Regulations & Guidelines for Clinical Research and Drug & Device Development

Drugs and Biologics - European Medicines Agency

Drugs and Biologics - FDA Approval

Medical Devices, Diagnostics, & Mobile Technology - FDA Approval and Clearance

FDA Guidance

FDA Educational Modules

FDA Information Caveats

  • FDA websites do not contain comprehensive approval packages for all FDA-approved drugs, devices, and biologics.
  • The amount of information provided in the FDA summary documents varies, and some information is redacted.
  • Additional information may be obtained through a Freedom of Information Act request or from FOI Services.
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