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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Draft OIG Compliance Program Guidance for Certain Medicare+Choice Organizations  Office of Inspector General (OIG) Proposed
Proposed Rule: Additional Safe Harbor Provisions Under the Anti-Kickback Statute  Office of Inspector General (OIG) Proposed
Requesting FDA Feedback on Combination Products : Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
List of Highest Priority Devices for Human Factors Review: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
2021 Rate Review Timeline Bulletin  Centers for Medicare & Medicaid Services (CMS) Proposed
Proposed Rule: OIG Anti-Kickback Provisions  Office of Inspector General (OIG) Proposed
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