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
Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Pyrogen and Endotoxins Testing: Questions and Answers  Food and Drug Administration (FDA) Final
Q10 Pharmaceutical Quality System  Food and Drug Administration (FDA) Final
Q11 Development and Manufacture of Drug Substances  Food and Drug Administration (FDA) Final
Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities)  Food and Drug Administration (FDA) Final
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex  Food and Drug Administration (FDA) Final
Q14 Analytical Procedure Development  Food and Drug Administration (FDA) Final
Q1A(R2) Stability Testing of New Drug Substances and Products  Food and Drug Administration (FDA) Final
Q1C Stability Testing for New Dosage Forms  Food and Drug Administration (FDA) Final
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.