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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
Q1 Stability Testing of Drug Substances and Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Modified Risk Tobacco Product Applications: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Material Threat Medical Countermeasure Priority Review Vouchers - Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5570 documents.