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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings : Draft Guidance for Industry   Food and Drug Administration (FDA) Proposed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Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed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 Supplementing the Guidance Provided in the Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Draft OIG Compliance Program Guidance for Pharmaceutical Manufacturers  Office of Inspector General (OIG) Proposed
Information Blocking; Office of Inspector General’s Civil Money Penalty Rules  Office of Inspector General (OIG) Proposed
Proposed Rule: Safe Harbor Under the Anti-Kickback Statute for the Waiver of Medicare SELECT Beneficiary Coinsurance and Deductible Amounts  Office of Inspector General (OIG) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part II Common Elements  Food and Drug Administration (FDA) Proposed
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