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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations 2001  Food and Drug Administration (FDA) Proposed
EDPPPS Proposed Edit Comments Letter V2 - December 2011  Centers for Medicare & Medicaid Services (CMS) Proposed
Treatment of Recovered CSR Amounts in MLR and Rebate Calculations   Centers for Medicare & Medicaid Services (CMS) Proposed
Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industy  Food and Drug Administration (FDA) Proposed
Best Practices in Developing Proprietary Names for Drugs  Food and Drug Administration (FDA) Proposed
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
CPG Sec 550.050 (Draft) Canned Ackee, Frozen Ackee, and Other Ackee Products – Hypoglycin A Toxin  Food and Drug Administration (FDA) Proposed
CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Reconditioning of Fish and Fishery Products by Segregation  Food and Drug Administration (FDA) Proposed
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