Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Warning Letters As Public “Leverage” Should Prompt GMP Compliance – Troy

This article was originally published in The Gray Sheet

Executive Summary

FDA Chief Counsel Daniel Troy emphasized the integral value of warning letters as public notification to a company's customers and competitors in a recent address to the University of Georgia's annual GMP conference

You may also be interested in...



Allen, Azar & Troy: FDA Legal Partners Streamline Enforcement Activity

HHS' decision to elevate FDA warning letter oversight from the Office of Regulatory Affairs to the Office of the Chief Counsel signals an attempt to keep a tighter rein on the agency in the absence of a commissioner

Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation

Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.

‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports

The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT016392

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel