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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
M4: The CTD -- Safety Questions and Answers  Food and Drug Administration (FDA) Final
M4E(R2): The CTD – Efficacy  Food and Drug Administration (FDA) Final
M4S: The CTD -- Safety  Food and Drug Administration (FDA) Final
M4S: The CTD -- Safety Appendices  Food and Drug Administration (FDA) Final
M9 Biopharmaceutics Classification System-Based Biowaivers  Food and Drug Administration (FDA) Final
Manufacture and Certification of Laser Kits (Laser Notice 13)  Food and Drug Administration (FDA) Final
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Master Files Part III - Guidance on Scientific and Technical Information  Food and Drug Administration (FDA) Final
Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations  Food and Drug Administration (FDA) Final
Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.