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 Combo Product GMP Reg Speeds Ahead Unchanged

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency decides to keep the proposed rule, issued in 2009, “largely identical” and denies requests to delay implementation a year.

You may also be interested in...



Device Industry Seeks More Clarity Following Combo Product GMP Final Rule

FDA’s final regulation outlines which manufacturing system requirements apply to products that have drug, device and/or biologic components. The Combination Products Coalition says key details need to be filled in by FDA with guidance.

Industry Seeks More Clarity Following Combo Product GMP Final Rule

FDA’s final regulation outlines which manufacturing system requirements apply to products that have drug, device and/or biologic components. An industry coalition says key details need to be filled in by FDA with guidance.

For Combination Product Development, Industry Says Talk Is Cheap

Industry official says FDA is responsive to questions from sponsors, but should issue more written guidance to help sponsors make development decisions.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS074779

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