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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
Hypertension: Developing Fixed-Dose Combination Drugs for Treatment  Food and Drug Administration (FDA) Final
Hypnotic Drugs--Clinical Evaluation  Food and Drug Administration (FDA) Final
Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)  Food and Drug Administration (FDA) Final
Identification Labels for Certain Class I Laser Products (Laser Notice 48)  Food and Drug Administration (FDA) Final
Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers  Food and Drug Administration (FDA) Final
Identification of Medicinal Products — Implementation and Use  Food and Drug Administration (FDA) Final
Immunogenicity Assessment for Therapeutic Protein Products  Food and Drug Administration (FDA) Final
Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection  Food and Drug Administration (FDA) Final
Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry  Food and Drug Administration (FDA) Final
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.