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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
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials: Guidance for Industry  Food and Drug Administration (FDA) Final
Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information: Guidance for Industry  Food and Drug Administration (FDA) Final
Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use: Guidance for Industry  Food and Drug Administration (FDA) Final
Electronic Source Data in Clinical Investigations: Guidance for Industry  Food and Drug Administration (FDA) Final
Electronic Submission of IND Safety Reports Technical Conformance Guide : Guidance for Industry  Food and Drug Administration (FDA) Final
Electronic Submission of Lot Distribution Reports: Guidance for Industry  Food and Drug Administration (FDA) Final
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies: Guidance for Industry  Food and Drug Administration (FDA) Final
Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization: Guidance for Industry  Food and Drug Administration (FDA) Final
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.