FDA Guidance Documents for U.S. Food & Drug Administration (FDA).
This information has recently been updated and is now available.
1. Links added to three new draft guidance documents:
Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review
http://www.fda.gov/MedicalDevices/Devic ... 267829.htm
Design Considerations for Pivotal Clinical Investigations for Medical Devices
http://www.fda.gov/MedicalDevices/Devic ... 265553.htm
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
http://www.fda.gov/downloads/Drugs/Guid ... 269919.pdf
2. Correction to CFR citation on this page:
Emergency Use of an Investigational Drug or Biologic - Information Sheet
http://www.fda.gov/RegulatoryInformatio ... 126491.htm