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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
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Processes and Practices Applicable to Bioresearch Monitoring Inspections: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.