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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
Orally Disintegrating Tablets: Guidance for Industry  Food and Drug Administration (FDA) Final
Orange Book Questions and Answers Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use —: Guidance for Industry  Food and Drug Administration (FDA) Final
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring: Guidance for Industry  Food and Drug Administration (FDA) Final
PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites: Guidance for Industry  Food and Drug Administration (FDA) Final
Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry  Food and Drug Administration (FDA) Final
PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance: Guidance for Industry  Food and Drug Administration (FDA) Final
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for Industry  Food and Drug Administration (FDA) Final
Pharmaceutical Components at Risk for Melamine Contamination: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.