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

Pharmaceutical Industry Slams FDA’s Guidance On Drug Substance Post- Approval Changes; Say More Alignment With ICH Needed

Executive Summary

Like the fabled Rip Van Winkle, FDA guidance on post-approval changes for drug substances has awakened after a long nap to a changed world. Industry is urging FDA to revise its draft in a way that’s less prescriptive and more in line with the science- and risk-based approaches, outlined in ICH Q8, Q9 and Q12 guidelines, that have emerged in the years after the agency withdrew its BACPAC guidance.

You may also be interested in...



Gottlieb: Valsartan API Crisis Spurs Drug GMP Revision

FDA commissioner discloses effort underway to tighten oversight of changes to active pharmaceutical ingredient manufacturing processes by rewriting parts of its drug GMP regulation.

FDA Guidance On Post-Approval Changes for Drug Substances Closes Regulatory Gap

FDA’s guidance on post-approval changes for drug substances fills in some of the missing pieces of the regulatory puzzle on how these changes are to be reported and documented. And it arrives just as FDA and other regulatory authorities are talking with industry about major upgrades to post-approval changes processes proposed in the International Council on Harmonization’s draft Q12 guideline.

FDA Would Establish Conditions for Swift Manufacturing Changes

FDA draft 'conditions established' guidance proposes to smooth the way for continual improvement of manufacturing processes for drugs and biologics by saying which manufacturing changes don't need to be reported.

Topics

UsernamePublicRestriction

Register

PS124352

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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