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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications  Food and Drug Administration (FDA) Final
Considerations in Demonstrating Interchangeability With a Reference Product: Update  Food and Drug Administration (FDA) Proposed
CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting  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
Facility Readiness: Goal Date Decisions Under GDUFA  Food and Drug Administration (FDA) Final
Diabetic Foot Infections: Developing Drugs for Treatment  Food and Drug Administration (FDA) Final
Accessing Enhanced Federal Medicaid Matching Rates for State Information Technology Expenditures to Improve Access to Mental Health and Substance Use Disorder Treatment and Care Coordination  Centers for Medicare & Medicaid Services (CMS) Final
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Guidance for Industry  Food and Drug Administration (FDA) Final
Medicaid and CHIP Managed Care Monitoring and Oversight Tools, including States’ Responsibility to Comply with Medicaid Managed Care and Separate CHIP Mental Health and Substance Use Disorder Parity Requirements  Centers for Medicare & Medicaid Services (CMS) Final
Processes and Practices Applicable to Bioresearch Monitoring Inspections: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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