1. Pink Sheet
  2. >>Archive

Regulatory Relief Explored for QbD Use in Post-Approval Changes

 
• By Joanne S. Eglovitch

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.

FDA should update its guidance on change control because it does not support science- and risk-based approaches to manufacturing changes, say agency and industry officials. As a result, the promised regulatory relief for manufacturers that embrace quality by design, or QbD, has not happened.

The status of change control policies in the U.S. and the European Union and their similarities and differences, particularly with...

Welcome to Pink Sheet

Create an account to read this article

Already a subscriber?

More from Archive

Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

More from Pink Sheet

Vanda Slams US FDA ‘Generic Bias,’ Again Seeks To Undo Hetlioz ANDA Approvals

 
• By Dave Wallace

In its latest attempt to curtail generic versions of Hetlioz, Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals, claiming an “unacceptable culture of bias toward approving generic drugs” at the agency.

Pink Sheet Podcast: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion Rises

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

Project Orbis: 2025 Shaping Up To Be A Strong Year For Canadian Approvals

 
• By Eliza Slawther

Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.