1.Thomas C. NovelliVice President, Government AffairsMedical Device Manufacturers Association2. National trade association focused onregulatory, legislative and legal issues…

Draft Guidance for Industry, MQSA Inspectors and FDA Staff The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System…

Guidance for Industry and FDA Staff Medical Glove Guidance Manual Document issued on January 22, 2008 This document supersedes Guidance for Medical Gloves – A Workshop…

        Additional copies are available from: Office of Nutrition, Labeling, and Dietary Supplements HFS-800 Center for Food Safety and Applied Nutrition Food…

CHAPTER 7: Scombrotoxin (Histamine) Formation This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or…

APPENDIX 4: Bacterial Pathogen Growth and Inactivation This guidance represents the Food and Drug Administrationâs (FDAâs) current thinking on this topic. It does not create…