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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review : Guidance for Industry  Food and Drug Administration (FDA) Final
Using Electronic Means to Distribute Certain Product Information: Guidance for Industry  Food and Drug Administration (FDA) Final
Cooperative Research: Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
Emergency Use of an Investigational Drug or Biologic: Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
Non-local IRB Review : Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
Payment and Reimbursement to Research Subjects: Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
Screening Tests Prior to Study Enrollment: Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
Sponsor - Investigator - IRB Interrelationship: Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.