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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
Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53)  Food and Drug Administration (FDA) Final
Aqueous Shunts - 510(k) Submissions - Guidance for Industry and for FDA Reviewers/Staff  Food and Drug Administration (FDA) Final
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations  Food and Drug Administration (FDA) Final
Assessing User Fees Under the Generic Drug User Fee Amendments of 2022  Food and Drug Administration (FDA) Final
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022  Food and Drug Administration (FDA) Final
Assessment of Abuse Potential of Drugs  Food and Drug Administration (FDA) Final
Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs  Food and Drug Administration (FDA) Final
Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Final
Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43)  Food and Drug Administration (FDA) Final
Benefit-Risk Assessment for New Drug and Biological Products  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.