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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
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Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Tissue Agnostic Drug Development in Oncology: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
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