Search Results for Lead

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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