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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
CPG Sec 575.100 Draft Revision - Pesticide Chemical Residues in Food - Enforcement Criteria  Food and Drug Administration (FDA) Proposed
CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's)  Food and Drug Administration (FDA) Proposed
Classification Categories for Certain Supplements Under BsUFA III  Food and Drug Administration (FDA) Proposed
CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines  Food and Drug Administration (FDA) Proposed
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention  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
CPG Sec 100.101 Crotalaria spp. Seeds in Grains  Food and Drug Administration (FDA) Proposed
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions  Food and Drug Administration (FDA) Proposed
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 28730 documents.

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