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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
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Collecting and Providing 702(b) Portions of FDA Official Samples: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Conducting Remote Regulatory Assessments Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry  Food and Drug Administration (FDA) Final
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5569 documents.