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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
Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects  Food and Drug Administration (FDA) Proposed
Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act  Food and Drug Administration (FDA) Proposed
Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry  Food and Drug Administration (FDA) Proposed
Regulatory Considerations for Prescription Drug Use-Related Software  Food and Drug Administration (FDA) Proposed
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities  Food and Drug Administration (FDA) Proposed
REMS Assessment: Planning and Reporting  Food and Drug Administration (FDA) Proposed
REMS Logic Model: A Framework to Link Program Design With Assessment  Food and Drug Administration (FDA) Proposed
Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act  Food and Drug Administration (FDA) Proposed
Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4744 documents.