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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
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Processes and Practices Applicable to Bioresearch Monitoring Inspections: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rare Diseases: Natural History Studies for Drug Development: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.