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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
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
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers  Food and Drug Administration (FDA) Final
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 5497 documents.