MedTech Crossroads

Learn more about the first FDA-approved cellular therapy for diabetes, Lantidra, in this MedTech Crossroads webinar. Gene Parunak, Managing Director at in2being, begins by announcing upcoming local and national med-tech-related events. MedTech Crossroads typically focuses on medical devices; however, this episode almost exclusively covers drugs and biologics.

FDA Approvals and Guidance

A significant portion of the webinar focuses on the FDA’s approval of Lantidra, which was developed by Celtrans. Lantidra, which is created using pancreatic cells from deceased donors, is the first cellular therapy for type 1 diabetes and involves infusing insulin-producing cells into patients to address insulin regulation issues. The treatment has shown promising results in non-randomized studies.

Gene uses the FDA’s approval of Lantidra to lead into a discussion of FDA guidance on conveying drug information through clear and accurate labeling and advertising. The FDA recommends using quantitative information—using absolute frequencies and consistent denominators and labeling graphs properly.

Real-World Data in FDA Oncology Submissions

The FDA has encouraged the inclusion of real-world data in oncology submissions. However, in practice, such submissions have often lacked basic information regarding study design, preventing the FDA from adequately assessing the data. Tune into the webinar to hear Gene’s summary of the FDA’s recent recommendations related to this topic.

EU Medical Device Regulation

We wrap up the webinar with a discussion of concerns raised by the European Union’s (EU’s) medical device regulation (MDR)—particularly related to its impact on medical devices for children.

Watch Our Weekly Webinar: MedTech Crossroads

Let us get you there.

We're ready to lead you from concept, to prototype, to FDA clearance. Let us show you how to push your project forward with a free project analysis. Are you ready to bring your medical device to market?

Contact us to request your free analysis today.