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 Promises Shorter, Quicker Drug GMP Warning Letters

This article was originally published in The Gold Sheet

Executive Summary

No more discursive treatises, the agency promises. From now on, drug GMP warning letters are going to be short and to the point – and they're going to arrive much more quickly.

You may also be interested in...



FDA Accelerates Inspection Process With New Concept Of Operations

'Concept of Operations' document spells out how FDA's realigned inspectorate and program offices will work together to accelerate drug manufacturing facility evaluations and inspections in line with generic and brand drug product reviews. Under the new approach, the agency expects to produce establishment inspection reports, facility classifications and warning letters more quickly, giving applicants more time to avoid manufacturing-related complete response letters.

How Europe’s Nomenclature System Works And Offers New Insights

Transparency linked to new device registration rules will provide new market analysis possibilities. Medtech Insight delved deeper into the benefits of the European Medical Device Nomenclature with two Italian executives who see its potential.

MHRA Offers Medtechs Extra Transition Time For UK Regulatory System Compliance

26 June saw the release finally of the UK government’s official response to the MHRA’s 2021 consultation on its post-Brexit medical devices regulatory framework. The considered response, held up by political and internal timing issues, represents an implementation plan for reform of the system. Crucially it allows industry extra compliance time.

Topics

Latest News
UsernamePublicRestriction

Register

PS000993

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