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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 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
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry  Food and Drug Administration (FDA) Final
Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 (Revised): Guidance for Industry  Food and Drug Administration (FDA) Final
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4744 documents.