Pink Sheet 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

FDA's Kopcha Presses Ahead On Quality Metrics Despite Industry Pushback

Executive Summary

The head of US FDA's drug quality office, Michael Kopcha, rebukes industry pushback that got White House's ear and demands more constructive feedback on quality metrics. Industry workshop participants come up with creative ideas, but FDA finds them problematic. Asked whether industry should dive in or wait and see on voluntary phase of metrics initiative that begins in January, another FDA official says, "That's a tough one."

You may also be interested in...



US FDA Opens Next Round Of Quality Metrics Debate With New Menu Of Options

Based on industry feedback from pilot programs, agency proposes for discussion a layered approach to quality metrics reporting that industry sectors and individual manufacturing facilities could tailor to their needs.

FDA Quality Office Looks Back At 2017: Reviews Accelerated, Inspections Realigned

US agency's Office of Pharmaceutical Quality continues to accelerate review and inspection processes, according to its first annual report. Meanwhile, the office's signature quality metrics initiative goes underground.

FDA Pilot Finds That Advance Records Yield More Inspection Findings

When FDA piloted the use of Section 706 authority to obtain records in advance of inspection, the US agency found the results included more inspection findings but not quicker inspections.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS121143

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