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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
Format and Content for the CMC Section of an Annual Report  Food and Drug Administration (FDA) Final
Format and Content of a REMS Document Guidance for Industry  Food and Drug Administration (FDA) Final
Format and Content of the Clinical and Statistical Sections of an Application  Food and Drug Administration (FDA) Final
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application  Food and Drug Administration (FDA) Final
Formatting, Assembling and Submitting New Drug and Antibiotic Applications*  Food and Drug Administration (FDA) Final
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry  Food and Drug Administration (FDA) Final
General Considerations for the Clinical Evaluation of Drugs  Food and Drug Administration (FDA) Final
General Guidelines for OTC Combination Products  Food and Drug Administration (FDA) Final
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry  Food and Drug Administration (FDA) Final
General/Specific Intended Use - Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.