F.D.A. Upgrades Recall of Some Chocolate Snacks to Highest Risk Level
The agency warned that the products, made by Cal Yee Farm, could have potentially serious or even deadly consequences because ...
Med Device Online1d
These Were FDA's Top Citation Issues For Data Quality In 2024
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate ...
RegEd Continues Expansion of Audit Management Capabilities in Support of FINRA’s Remote Inspections Pilot Program
For firms opting into the Remote Inspections Pilot Program, RegEd provides the necessary tools to manage remote inspections while meeting FINRA’s oversight and reporting requirements. For those ...
Amid recalls, Minnesota medtech exec says she was pressured to disregard safety law
Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...
Data Integrity Auditor Masterclass Training Course: Concept of Fata integrity from the Perspective of GxP Audits (ONLINE EVENT: February 4-5, 2025)
The "Data Integrity Auditor Masterclass Training Course" conference has been added to ResearchAndMarkets.com's offering. Data integrity has received more attention than ever before in the last decade ...
Tougher security required for poultry indemnity payments after repeated bird flu infections
Under new rules, poultry facilities seeking indemnity payments after repeated bird flu infections must show biosecurity ...
FDA Inspections Seminar: Fundamentals and the Ground Rules on How to Prepare for and Survive an FDA Inspection (ONLINE EVENT: February 24-25, 2025)
The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...
Halted research, disciplined doctors: internal audit finds Kaiser ignored patient protections in California study
Two top clinicians have been disciplined amid growing concern that Kaiser’s system for monitoring research safety and ethics ...
Acsh.org5d
FDA’s Failures in the Infant Formula Debacle Cry Out for Reform
There were unforgiveable shortcomings in management, which included critical information not reaching senior officials as ...