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 POST-APPROVAL CHANGE GUIDANCES

This article was originally published in The Gold Sheet

Executive Summary

on packaging components and analytical methods will move forward based on a June workshop at which FDA and industry shared ideas and expectations for the two documents. Participants agreed that there should be less rigorous regulatory standards when changing to packaging components used in similar, approved products. While the workshop discussions on AMPAC did not benefit from a preconceived draft like the one presented by PhRMA for PACPAC, a consensus did emerge on the general handling of basic types of method changes. FDA is revising its existing SUPACs to reflect the FDAMA legislation and CFR 314.70 revisions, and is refocusing on completing its bulk drug and sterile product PAC documents.

You may also be interested in...



McKinsey Survey Highlights Progress, Challenges in Adoption of QbD

Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.

Manufacturers Encouraged to Enhance Clinical Relevance of Quality With QbD

Using QbD to set specs that make a difference to patients is hard but important work, FDA's Woodcock says. Prasugrel, levothyroxine, pallodone examples explored. How to establish a 'work space.' How to make the right correlations.

Biotech QbD Encounters Uncertainties Over Definitions and Regulatory Relief

As biotech firms begin to pilot QbD they wrestle with FDA over non-critical process parameters, postapproval changes and more. They are exploring how to define design spaces, change them, identify their edges. And they're still wondering what regulatory relief they might get in return for investing in quality-by-design studies.

Topics

Related Companies

UsernamePublicRestriction

Register

LL009864

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