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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
Testing for Biotin Interference in In Vitro Diagnostic Devices: Guidance for Industry  Food and Drug Administration (FDA) Final
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up: Guidance for Industry  Food and Drug Administration (FDA) Final
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP): Guidance for Industry  Food and Drug Administration (FDA) Final
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers : Guidance for Industry  Food and Drug Administration (FDA) Final
Tobacco Health Document Submission (Revised): Guidance for Industry  Food and Drug Administration (FDA) Final
Tobacco Product Master Files: Guidance for Industry  Food and Drug Administration (FDA) Final
Tobacco Retailer Training Programs: Guidance for Industry  Food and Drug Administration (FDA) Final
Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective: Guidance for Industry  Food and Drug Administration (FDA) Final
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials: Guidance for Industry  Food and Drug Administration (FDA) Final
Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis): Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.