...are being launched that will help transform the way CMC information is submitted and reviewed in the U.S. The new NDA and ANDA pilots are intended to better focus CMC reviews on the design, development and manufacturing science behind quality, resulting in more effective and efficient regulatory and manufacturing processes. On the NDA side, FDA’s Office of New Drug Chemistry intends to work hand in hand with volunteer companies in developing and clearing a dozen applications that will embody the principles of quality by design, product knowledge and process understanding central to the new regulatory paradigm. The Office of Generic Drugs, meanwhile, is launching an ANDA "question-based review" model that will drive both applicants and reviewers to focus directly on what is most critical to the quality assessment process. The pilots will be accompanied by a workshop in early October to debate the relevant challenges and issues and help target the new CMC review procedures and guidance.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
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.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
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.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
