Search Results for Lead

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FDA Warns Lead-Testing Diagnostics Company By Zachary Brennan - Published 23 October 2017

The US Food and Drug Administration (FDA) on Monday sent a warning letter to Massachusetts-based Magellan Diagnostics, a subsidiary of Meridian Bioscience, finding the company made significant changes to its lead-testing devices without notifying the agency, among other violations.

Categories: News, US, CDRH, Due Diligence, Medical Devices, Quality

Tags: lead tests, Magellan Diagnostics, Meridian Bioscience

FDA: Lead Test Company May Have Violated Federal Law By Michael Mezher - Published 13 July 2017

The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems.

Categories: News, US, CDRH, In vitro diagnostics

Tags: LeadCare, Lead Testing, Magellan Diagnostics, Form 483

FDA Warns of False Results With Common Lead Test By Michael Mezher - Published 17 May 2017

In the wake of a lead contamination crisis affecting cities across the country, the US Food and Drug Administration (FDA) on Wednesday warned that a commonly used line of lead testing systems may provide falsely low results under certain circumstances.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: Lead, Magellan Diagnostics, LeadCare

EMA Issues Guidance on Clarification Meetings By Michael Mezher - Published 10 February 2015

The European Medicines Agency (EMA) is looking to increase transparency between its committees and pharmaceutical companies under a new guideline that went into effect in February 2015.

Categories: News, Europe, EMA, Communication, Drugs, Regulatory strategy, Submission and registration

Tags: List of Questions, List of Outstanding Issues, LoQ, LoOI, CHMP, EMA Product Lead

EMA Revamping How it Handles Submission of Applications and Requests for Advice By Alexander Gaffney, RAC - Published 27 March 2014

Categories: EMA

Tags: EPL, EMA product Lead, Procedure Manager, Latest News, EU

Report: New Troubles for Medical Device Manufactuers, FDA After Faulty Leads Lead to Questions By Alexander Gaffney - Published 10 April 2012

Categories: FDA

Tags: Medtronic, St. Jude, Lead, Heart, Defibrillator, Leads, Report, Adverse Event, Latest News, Guidant, medical device