Presently, although there is no requirement for submitting individual adverse event human case reports involving food products to the FDA the Agency does have the expectation that manufacturers have a strong quality management system in place to document and investigate adverse events. This will allow the manufacturer to identify unexpected new risks or hazards with their distributed food products and …
EPA and FDA CVM Hold Joint Public Meeting to Hear Comments on Modernization Plan
Last Wednesday, March 22nd, several members of SafetyCall’s regulatory team sat in on EPA and FDA’s Center for Veterinary Medicine (CVM) first joint public meeting in which they presented a general and high level rationale and framework for their proposed modernization plan and heard the public’s questions and comments. EPA and FDA gave no specific updates during the …