regulatory training program

FDA expands its internal program to learn more from companies about medical device manufacturing

The Food and Drug Administration is expanding its Experiential Learning Program, with aims to learn more about the manufacture medical technologies – particularly in vitro diagnostics and next-gen sequencing, RAPS reports. A new notice says that FDA’s learning program will expand into 34 areas of interest – including understanding the manufacturing process of continuous glucose monitors, insulin pumps, mass […]

By Meghana Keshavan

Daily

An FDA “curriculum” helps guide medical device startups through regulatory maze

It’s tough for medical device companies to get that stamp of FDA approval, but the labyrinthine regulatory pathway certainly doesn’t help things. Regulators want to change that: “…we learned that the delivery of new therapies to patients can be accelerated if medical device innovators — including entrepreneurs and university students and faculty — understand FDA’s regulatory processes,” FDA researcher Francis […]

By Meghana Keshavan

With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?

Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.