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

Combination Product Oversight Will Be Partly Affected By Drug GMP Initiative

This article was originally published in The Gray Sheet

Executive Summary

FDA's initiative to enhance pharmaceutical good manufacturing practices will apply to combination products that have biological drug or drug components

You may also be interested in...



CDRH 483s Will Include Language Developed Under GMP Initiative

FDA is seeking to reconcile device Form 483s with new language being added to drug inspection documents under the auspices of CDER's GMP initiative, according to FDA Assistant Commissioner of Regulatory Affairs Steve Niedelman

CDRH 483s Will Include Language Developed Under GMP Initiative

FDA is seeking to reconcile device Form 483s with new language being added to drug inspection documents under the auspices of CDER's GMP initiative, according to FDA Assistant Commissioner of Regulatory Affairs Steve Niedelman

Part 11 Risk-Based Approach To Be Communicated To FDA Field Staff

Device manufacturers should prepare for variability in how inspectors interpret Part 11 requirements as FDA gears-up to communicate more specific guidelines to its field staff in the next several weeks

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT017048

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