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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
CPG Sec 615.115 Extralabel Use of Medicated Feeds for Minor Species  Food and Drug Administration (FDA) Final
CPG Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval  Food and Drug Administration (FDA) Final
CPG Sec. 101.100 FDA Considerations for Recommending Charges for Causing the Introduction of Violative Products into Interstate Commerce  Food and Drug Administration (FDA) Final
CPG Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs)  Food and Drug Administration (FDA) Final
CPG Sec. 230.140 Evaluation and Processing Post Donation Information Reports is obsolete and was withdrawn on 7/16/2018.  Food and Drug Administration (FDA) Final
CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor  Food and Drug Administration (FDA) Final
CPG Sec. 250.500- Plasma Brokers - Registration and Compliance with Good Manufacturing Practices is obsolete and was withdrawn on 7/16/2018.  Food and Drug Administration (FDA) Final
CPG Sec. 280.100 - Stability Requirements - Licensed In Vitro Diagnostic Products  Food and Drug Administration (FDA) Final
CPG Sec. 280.110- Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood Grouping Reagents  Food and Drug Administration (FDA) Final
CPG Sec. 300.400 Contamination of Devices Labeled as Sterile  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.