...manufacturers are exploring how quality-by-design concepts apply in the context of the complexities of the drug/device interface. The challenges surrounding the control of leachables and extractables and how the supplier relationships fit into the QbD effort are particular focal points of attention. New industry guidances on L&Es and supplier GMPs from the Product Quality Research Institute and the International Pharmaceutical Aerosol Consortium on Regulation and Science, respectively, are helping move the dialogue forward and tighten the communication linkages. [Summary reports from three breakout sessions at a recent IPAC-RS conference – on supplier quality control, parametric tolerance interval testing and application of ISO standards – are provided.]
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.’
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
