This guidance for industry provides the Agency’s current thinking on how to evaluate out-of-specification (OOS) test results: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision.
Tag: FDA
U.S. Senate narrowly confirms Dr. Robert Califf to lead FDA for second time – Reuters
"Calif[f], 70, is a well-regarded cardiologist and researcher who takes the helm at the FDA for a second time 13 months after it last had a permanent leader."
Jennifer Payne Named President Of SkillsPlus Intl Inc.
Jennifer Payne - President, SkillsPlus International Inc. | SkillsPlus Intl Inc. announces its new president, Jennifer Payne. She assumes responsibility for all administrative needs, and for managing CGMP contract trainers.
The Team – SkillsPlus International Inc.
The team at SkillsPlus International Inc. | Learn more about our team, and visit our new website: https://skillsplusinc.com/about.htm
FDA Issues New DSCSA Guidances
To help our stakeholders understand these requirements, the FDA is issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain.