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HHS Guidance Submissions

HHS Guidance

* Metadata including document title and file name are searchable, however, the contents of the guidance documents that are not in HTML format are currently not keyword searchable.

Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry  Food and Drug Administration (FDA) Proposed
CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality  Food and Drug Administration (FDA) Proposed
Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document  Food and Drug Administration (FDA) Proposed
CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for Infants  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues  Food and Drug Administration (FDA) Proposed
Drug Master Files Guidance for Industry  Food and Drug Administration (FDA) Proposed
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry  Food and Drug Administration (FDA) Proposed
Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products  Food and Drug Administration (FDA) Proposed
Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 46923 documents.

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