...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 Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.
US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.
Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.
