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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers  Food and Drug Administration (FDA) Proposed
Provision of Medicaid and CHIP Services to Incarcerated Youth  Centers for Medicare & Medicaid Services (CMS) Final
Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma: Guidance for Industry  Food and Drug Administration (FDA) Final
Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for Industry  Food and Drug Administration (FDA) Final
Consolidated Appropriations Act, 2023 Amendments to Provider Directory Requirements  Centers for Medicare & Medicaid Services (CMS) Final
Application User Fees for Combination Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older  Food and Drug Administration (FDA) Final
Dental Curing Lights - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3337 documents.

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