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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
SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation: Guidance for Industry  Food and Drug Administration (FDA) Final
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation: Guidance for Industry  Food and Drug Administration (FDA) Final
Temporary Policies for Compounding Certain Parenteral Drug Products: Guidance for Industry  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4041 documents.