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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
Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry  Food and Drug Administration (FDA) Final
Container Closure System and Component Changes: Glass Vials and Stoppers  Food and Drug Administration (FDA) Final
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers  Food and Drug Administration (FDA) Final
Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA Reviewers  Food and Drug Administration (FDA) Final
Contents of a Complete Submission for the Evaluation of Proprietary Names  Food and Drug Administration (FDA) Final
Controlled Correspondence Related to Generic Drug Development  Food and Drug Administration (FDA) Final
Convenience Kits Interim Regulatory Guidance  Food and Drug Administration (FDA) Final
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
CPG Sec 690.800 Compliance Policy Guide Salmonella in Food for Animals  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.