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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Crohn’s Disease: Developing Drugs for Treatment  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
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products  Food and Drug Administration (FDA) Proposed
CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines  Food and Drug Administration (FDA) Proposed
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products  Food and Drug Administration (FDA) Proposed
Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications  Food and Drug Administration (FDA) Proposed
CPG Sec 540.275 (Draft) Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of Escherichia coli  Food and Drug Administration (FDA) Proposed
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry  Food and Drug Administration (FDA) Proposed
Benefit-Risk Considerations for Product Quality Assessments  Food and Drug Administration (FDA) Proposed
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3207 documents.

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