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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Guidance for Industry: FDA's Voluntary Qualified Importer Program  Food and Drug Administration (FDA) Final
CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS 1809-FC)  Centers for Medicare & Medicaid Services (CMS) Final
CPG Sec 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24)  Food and Drug Administration (FDA) Final
M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms  Food and Drug Administration (FDA) Final
CVM GFI #293 - FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients  Food and Drug Administration (FDA) Final
Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination  Food and Drug Administration (FDA) Final
Drug Interaction Information in Human Prescription Drug and Biological Product Labeling  Food and Drug Administration (FDA) Proposed
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA  Food and Drug Administration (FDA) Final
Core Patient-Reported Outcomes in Cancer Clinical Trials: Guidance for Industry  Food and Drug Administration (FDA) Final
Postoperative Nausea and Vomiting: Developing Drugs for Prevention  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3312 documents.

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