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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)  Food and Drug Administration (FDA) Proposed
CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallus  Food and Drug Administration (FDA) Proposed
CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines  Food and Drug Administration (FDA) Proposed
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs  Food and Drug Administration (FDA) Proposed
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
CPG Sec 555.320 Listeria monocytogenes  Food and Drug Administration (FDA) Proposed
CVM GFI #142 (VICH GL29) Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)  Food and Drug Administration (FDA) Proposed
CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's)  Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3294 documents.

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