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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Considerations in Demonstrating Interchangeability With a Reference Product: Update  Food and Drug Administration (FDA) Proposed
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs  Food and Drug Administration (FDA) Proposed
Classification Categories for Certain Supplements Under BsUFA III  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
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements  Food and Drug Administration (FDA) Proposed
CPG Sec 555.320 Listeria monocytogenes  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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