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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Compliance Policy Guides Index  Food and Drug Administration (FDA) Final
CPG Sec. 300.500 *Reprocessing of Single Use* Devices  Food and Drug Administration (FDA) Final
Dairy Products Sec. 527.300 Microbial Contaminants & Alkaline Phosphatase Activity  Food and Drug Administration (FDA) Final
Final In Vivo Bioavailability-Bioequivalence Studies- Analytical  Food and Drug Administration (FDA) Final
NEPA_Final_Guidance  Food and Drug Administration (FDA) Final
New/Revised/Withdrawn Guidances 2014  Food and Drug Administration (FDA) Final
Sample WHO Certificate for Quality of a Pharmaceutical Product  Food and Drug Administration (FDA) Final
eCTD v4.0 Implementation Package DRAFT Specification for Submission Formats v2.0  Food and Drug Administration (FDA) Proposed
REASANZ™ (SERELAXIN)  Centers for Medicare & Medicaid Services (CMS) Final
A New ICD-10-PCS Code For the Administration of Dalbavancin  Centers for Medicare & Medicaid Services (CMS) Final
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