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
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial: Guidance for Industry  Food and Drug Administration (FDA) Final
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes: Guidance for Industry  Food and Drug Administration (FDA) Final
Submission of Warning Plans for Cigars: Guidance for Industry  Food and Drug Administration (FDA) Final
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees: Guidance for Industry  Food and Drug Administration (FDA) Final
SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation: Guidance for Industry  Food and Drug Administration (FDA) Final
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation: Guidance for Industry  Food and Drug Administration (FDA) Final
Temporary Policies for Compounding Certain Parenteral Drug Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19 : Guidance for Industry  Food and Drug Administration (FDA) Final
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.