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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
SPL Standard for Content of Labeling Technical Qs & As  Food and Drug Administration (FDA) Proposed
Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry  Food and Drug Administration (FDA) Proposed
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products: Draft Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Solicitation of Information and Recommendations for Developing OIG Compliance Program Guidance for Certain Medicare+Choice Organizations  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  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 for Individual and Small Group Physician Practices  Office of Inspector General (OIG) Proposed
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees  Office of Inspector General (OIG) Proposed
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