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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
Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents: Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations for Plasmid DNA Vaccines for Infectious Disease Indications: Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology: Guidance for Industry  Food and Drug Administration (FDA) Final
Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES: Guidance for Industry  Food and Drug Administration (FDA) Final
Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4128 documents.