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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
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements  Food and Drug Administration (FDA) Proposed
Clinical Pharmacology Considerations for Peptide Drug Products  Food and Drug Administration (FDA) Proposed
Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention  Food and Drug Administration (FDA) Proposed
E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.