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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Collecting and Providing 702(b) Portions of FDA Official Samples: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Conducting Remote Regulatory Assessments Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Current Good Manufacturing Practice for Medical Gases: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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