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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
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry  Food and Drug Administration (FDA) Proposed
Acromegaly: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment  Food and Drug Administration (FDA) Proposed
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers  Food and Drug Administration (FDA) Proposed
Advanced Manufacturing Technologies Designation Program  Food and Drug Administration (FDA) Final
Alcoholism: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
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
This Guidance Portal contains 4741 documents.