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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
Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA Reviewers/Staff  Food and Drug Administration (FDA) Final
Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs  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
Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act  Food and Drug Administration (FDA) Final
Guidance for Industry: Proper Labeling of Honey and Honey Products  Food and Drug Administration (FDA) Final
Guidance for Industry: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for "Eligible" Infant Formulas  Food and Drug Administration (FDA) Final
E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility  Food and Drug Administration (FDA) Final
Improving Teacher-Child Interactions: Using the CLASS in Head Start Preschool Programs  Administration for Children and Families (ACF) Final
Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh - Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance  Food and Drug Administration (FDA) Final
FDA Animal Products Database Data Entry Form  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.