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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
Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry  Food and Drug Administration (FDA) Final
Cooperative Manufacturing Arrangements for Licensed Biologics: Guidance for Industry  Food and Drug Administration (FDA) Final
Core Patient-Reported Outcomes in Cancer Clinical Trials: Guidance for Industry  Food and Drug Administration (FDA) Final
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions: Guidance for Industry  Food and Drug Administration (FDA) Final
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry  Food and Drug Administration (FDA) Final
COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention: Guidance for Industry  Food and Drug Administration (FDA) Final
Current Good Manufacturing Practice for Phase 1 Investigational Drugs: Guidance for Industry  Food and Drug Administration (FDA) Final
Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry  Food and Drug Administration (FDA) Final
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software: Guidance for Industry  Food and Drug Administration (FDA) Final
Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.