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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
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers  Food and Drug Administration (FDA) Proposed
Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause  Food and Drug Administration (FDA) Proposed
Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals  Food and Drug Administration (FDA) Final
E22 General Considerations for Patient Preference Studies  Food and Drug Administration (FDA) Proposed
Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality  Food and Drug Administration (FDA) Proposed
Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5569 documents.