Major Eye Drop Recall Shows Manufacturing and Inspection Issues

Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact Massive eye drop recall reflects...

When a Small Process Failure Becomes a Patient Safety Event

Medical Device Safety Alert Erbe cryoprobes may rupture or burst Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact What the...

Moringa and the “Invisible Outbreak” Problem

The Invisible Outbreak in Dietary Supplements Moringa identified as a source of Salmonella Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact Moringa and...

Do Not Blame FDA for Lax Oversight of Dietary Supplements 

Do Not Blame FDA for Lax Oversight of Dietary Supplements MDP Policy Commentary Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers A Regulatory System Designed to Fail  The recent...

Has Industry Self-Regulation Been Effective? 

Supplement Industry Self-Regulation Mixed results related to manufacturer prominence Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Has Industry Self-Regulation...