Skip to main content
U.S. flag

An official website of the United States government

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.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for Industry  Food and Drug Administration (FDA) Final
Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical: Guidance for Industry  Food and Drug Administration (FDA) Final
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
An Acceptable Circular of Information for the Use of Human Blood and Blood Components: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.