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University of Washington Health Sciences Library

Drugs and Medical Devices: Development and Regulatory Approval

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Health Care Reimbursement

Market Reports, News, Trade Publications

Standards

Device Specifications

Standard of Care: Clinical Practice Summaries

Drug Information

Scientific and Patent Publications

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Clinical Trials

Regulations & Guidelines for Clinical Research and Drug & Device Development

Drugs and Biologics - FDA Approval

Medical Devices and Diagnostics - FDA Approval and Clearance

FDA Approval Process

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.

Drugs and Biologics - European Medicines Agency

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