We are pleased to announce the ARMI | BioFabUSA Spring 2019 Project Calls. We encourage you to read this blog and the project call documentation, which is available on our community portal.
The PMOA of a combination product is the action that is mainly responsible for how the product achieves its intended therapeutic effect (i.e., drug, device, or biologic). Thus, an understanding of the PMOA is directly linked to an understanding of the statutory definitions of a drug, device, and biologic.
Robert J. Tomasetta founded Automated Control Concepts Inc. (ACC) in 1983, leaving the confines of the General Electric Programmable Logic Controller (PLC) business to open ACC’s first office in Union, New Jersey. He focused on programming those, at the time, very “mysterious” programmable controller devices.
Nearly twenty years ago, Dr. Marc Hedrick at Cytori Therapeutics predicted that in years to come humans would someday donate their adult stem cells from fat tissue the way blood was, and is, donated today in order to cure diseases.Fast forward to 2019 and Dr. Jeffrey Gimble, CEO of LaCell is doing just that and more.