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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings : Draft Guidance for Industry   Food and Drug Administration (FDA) Proposed
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Solicitation of Information and Recommendations for Developing OIG Compliance Program Guidance for the Durable Medical Equipment Industry  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Solicitation of Comments on the OIG/HCFA Special Advisory Bulletin on the Patient Anti-Dumping Statute  Office of Inspector General (OIG) Proposed
Draft OIG Compliance Program Guidance for Ambulance Suppliers  Office of Inspector General (OIG) Proposed
Proposed Rule: Additional Safe Harbor Provisions Under the Anti-Kickback Statute  Office of Inspector General (OIG) Proposed
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