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
CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports  Food and Drug Administration (FDA) Final
Codevelopment of Two or More New Investigational Drugs for Use in Combination  Food and Drug Administration (FDA) Final
Color Additive Petitions - Medical Devices  Food and Drug Administration (FDA) Final
Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment  Food and Drug Administration (FDA) Final
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA  Food and Drug Administration (FDA) Final
Competitive Generic Therapies  Food and Drug Administration (FDA) Final
Compliance Guide for Cabinet X-Ray Systems  Food and Drug Administration (FDA) Final
Compliance Guide for Laser Products (FDA 86-8260)  Food and Drug Administration (FDA) Final
Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry  Food and Drug Administration (FDA) Final
Compliance Policy Guide CPG Sec. 110.650 Weekly Entry Filing Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.