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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Proposed Rule: Ambulance Restocking Safe Harbor under the Anti-Kickback Statute  Office of Inspector General (OIG) Proposed
Draft Instructions for Completing the Medicare Advantage Bid Pricing Tools for CY2023  Centers for Medicare & Medicaid Services (CMS) Proposed
Proposed Rule: Safe Harbor Anti-Kickback Provisions  Office of Inspector General (OIG) Proposed
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs  Food and Drug Administration (FDA) Proposed
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations  Food and Drug Administration (FDA) Proposed
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's)  Food and Drug Administration (FDA) Proposed
CVM GFI #264 Standardized Medicated Feed Assay Limits  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government  Food and Drug Administration (FDA) Proposed
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