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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Solicitation of Information and Recommendations for Developing Compliance Program Guidance for Recipients of NIH Research Grants  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review Staff  Food and Drug Administration (FDA) Proposed
Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti- Kickback Statute and Beneficiary Inducements CMP  Office of Inspector General (OIG) Proposed
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