Skip to main content
U.S. flag

An official website of the United States government

HHS Guidance Submissions

Search HHS Guidance Documents

 

Filter Guidance Documents by ...

Title OpDiv/StaffDiv Guidance Status Issue Date
E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)  Food and Drug Administration (FDA) Final
E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers  Food and Drug Administration (FDA) Final
E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting  Food and Drug Administration (FDA) Final
E2E Pharmacovigilance Planning  Food and Drug Administration (FDA) Final
E2F Development Safety Update Report  Food and Drug Administration (FDA) Final
E3 Structure and Content of Clinical Study Reports  Food and Drug Administration (FDA) Final
E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1)  Food and Drug Administration (FDA) Final
E4 Dose-Response Information to Support Drug Registration  Food and Drug Administration (FDA) Final
E5 Ethnic Factors in the Acceptability of Foreign Clinical Data  Food and Drug Administration (FDA) Final
E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)  Food and Drug Administration (FDA) Final
This Guidance Portal contains 49871 documents.

Petition Submissions

To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov

CDC

CMS

* This PDF is not Section 508 compliant. Assistive Technology users should contact good.guidance@hhs.gov if they experience any difficulties.