Skip to main content
U.S. flag

An official website of the United States government

HHS Guidance Submissions

Search HHS Guidance Documents

 

Filter Guidance Documents by ...

Title OpDiv/StaffDiv Guidance Status Issue Date
Q3C Tables and List Rev. 4  Food and Drug Administration (FDA) Final
Q3C: Appendix 5  Food and Drug Administration (FDA) Final
Q3D(R1) ELEMENTAL IMPURITIES  Food and Drug Administration (FDA) Final
Q4B Annex 10: Polyacrylamide Gel Electrophoresis General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex 5: Disintegration Test General Chapter  Food and Drug Administration (FDA) Final
This Guidance Portal contains 49871 documents.

Petition Submissions

To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov

CDC

CMS

* This PDF is not Section 508 compliant. Assistive Technology users should contact good.guidance@hhs.gov if they experience any difficulties.