Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

FDA Proposes to Ease Reporting Burden for Low-Risk CMC Changes

This article was originally published in The Gold Sheet

Executive Summary

FDA relaxes approach to 40 types of low-risk manufacturing changes.

You may also be interested in...



Regulatory Relief Explored for QbD Use in Post-Approval Changes

There is little evidence that using QbD for managing post-approval changes will confer regulatory relief to pharmaceutical manufacturers. FDA and industry officials say that current FDA guidance documents on change control are not keeping up with the science.

Drug Makers Catch FDA’s Drift, Look to Rid Processes of Variability

FDA officials say that drug manufacturers need to have better trending and monitoring programs in place to detect process drift in drug manufacture. They note that many of the controls needed to prevent process drift are already embodied in existing GMP regulations but are underutilized.

Drug Makers Catch FDA’s Drift, Look to Rid Processes of Variability

FDA officials say that drug manufacturers need to have better trending and monitoring programs in place to detect process drift in drug manufacture. They note that many of the controls needed to prevent process drift are already embodied in existing GMP regulations but are underutilized.

UsernamePublicRestriction

Register

LL1135495

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