International Regulators Seek Collaboration On Infusion Pump Standards
This article was originally published in The Gray Sheet
Executive Summary
International collaboration on infusion pump standards could help reduce safety risks from the devices, according to Canadian and Swedish regulators who attended FDA's recent workshop on infusion pump improvements
You may also be interested in...
FDA To Impose New Pre-market Requirements On Infusion Pump Makers
To address widespread safety issues, FDA plans to put in place new requirements for external infusion pump 510(k) submissions, including asking device makers to provide an "assurance case" to document and support safety design specifications
Scrip M&A Podcast: Which Companies Could Be Acquired Next?
The editorial team from Scrip discusses the M&A potential of various emerging biopharmas, such as Viking, Verona, Altimmune, Xenon and Crinetics.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.