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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Core Patient-Reported Outcomes in Cancer Clinical Trials: Guidance for Industry  Food and Drug Administration (FDA) Final
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA  Food and Drug Administration (FDA) Final
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method  Food and Drug Administration (FDA) Proposed
Postoperative Nausea and Vomiting: Developing Drugs for Prevention  Food and Drug Administration (FDA) Proposed
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Guidance for Industry  Food and Drug Administration (FDA) Final
Requests for Reconsideration at the Division Level Under GDUFA  Food and Drug Administration (FDA) Final
CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food  Food and Drug Administration (FDA) Final
Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Temporary Policies for Compounding Certain Parenteral Drug Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Notice of Technology and Process Upgrades for Account Transfer Functionality for States Served by Marketplaces on the Federal Platform  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 3294 documents.

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