Skip to main content
U.S. flag

An official website of the United States government

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.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications: Guidance for Industry  Food and Drug Administration (FDA) Final
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry  Food and Drug Administration (FDA) Final
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment : Guidance for Industry  Food and Drug Administration (FDA) Final
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection: Guidance for Industry  Food and Drug Administration (FDA) Final
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry  Food and Drug Administration (FDA) Final
Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (*Revised): Guidance for Industry  Food and Drug Administration (FDA) Final
Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions (*Revised): Guidance for Industry  Food and Drug Administration (FDA) Final
Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases: Guidance for Industry  Food and Drug Administration (FDA) Final
Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.