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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
CVM GFI #290 (VICH GL61) – Pharmaceutical Development  Food and Drug Administration (FDA) Proposed
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
CVM GFI #187A Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach  Food and Drug Administration (FDA) Final
Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels: Guidance for Industry  Food and Drug Administration (FDA) Final
Small Entity Compliance Guide: Revocation of Uses of Partially Hydrogenated Oils in Foods  Food and Drug Administration (FDA) Final
CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers  Food and Drug Administration (FDA) Final
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs  Food and Drug Administration (FDA) Proposed
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products  Food and Drug Administration (FDA) Proposed
Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products  Food and Drug Administration (FDA) Proposed
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