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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 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact  Food and Drug Administration (FDA) Proposed
Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CPG Sec 550.050 (Draft) Canned Ackee, Frozen Ackee, and Other Ackee Products – Hypoglycin A Toxin  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
CPG Sec 100.101 Crotalaria spp. Seeds in Grains  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
Considerations for Rescinding Breakthrough Therapy Designation  Food and Drug Administration (FDA) Proposed
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological 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
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.