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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
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications  Food and Drug Administration (FDA) Final
ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions  Food and Drug Administration (FDA) Final
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry  Food and Drug Administration (FDA) Proposed
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance  Food and Drug Administration (FDA) Proposed
Applications Covered by Section 505(b)(2)  Food and Drug Administration (FDA) Proposed
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.