...for new and generic drugs are demonstrating the progress and the remaining challenges in building a stronger QbD foundation for the CMC review process. With one application cleared and several more under review in the NDA pilot, experience is now growing on how to shape a QbD-based filing from which more regulatory flexibility can flow. How detailed the QbD information should be and how to design a regulatory agreement that will clarify the ongoing commitments are among the issues generating discussion as the NDA pilot proceeds. The Office of Generic Drugs is also digesting the initial positive experience with its question-based review initiative integrating QbD principles into the ANDA review process. [An update on the NDA CMC pilot program by Office of New Drug Quality Assessment official Chi-wan Chen at the DIA annual meeting in late June and summaries by industry participants of their firms’ experience with the NDA and ANDA initiatives are included.]
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.’
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
