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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
Analytical Procedures and Methods Validation for Drugs and Biologics  Food and Drug Administration (FDA) Final
ANDA Submissions -- Refuse-to-Receive Standards Rev.2  Food and Drug Administration (FDA) Final
ANDAs: Stability Testing of Drug Substances and Products  Food and Drug Administration (FDA) Final
ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers  Food and Drug Administration (FDA) Final
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule - Concept Paper  Food and Drug Administration (FDA) Final
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule_09  Food and Drug Administration (FDA) Final
Annex 13 Bulk Density and Tapped Density of Powders General Chapter  Food and Drug Administration (FDA) Final
Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry  Food and Drug Administration (FDA) Final
Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval  Food and Drug Administration (FDA) Final
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.