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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
INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information: Guidance for Industry  Food and Drug Administration (FDA) Final
Industry Supported Scientific and Educational Activities: Guidance for Industry  Food and Drug Administration (FDA) Final
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act: Guidance for Industry  Food and Drug Administration (FDA) Final
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments: Guidance for Industry  Food and Drug Administration (FDA) Final
Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs: Guidance for Industry  Food and Drug Administration (FDA) Final
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops: Guidance for Industry  Food and Drug Administration (FDA) Final
Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 : Guidance for Industry  Food and Drug Administration (FDA) Final
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Guidance for Industry  Food and Drug Administration (FDA) Final
Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4128 documents.