Army holds medical product development workshop
Jeremiah J. Kelly, Esq., of the USAMRMC Office of the Staff Judge presented the workshop, which is part of an ongoing series of classes called Navigating Medical Product Acquisition in the FDA, dcmilitary.com reports.
The FDA regulates the safety, efficacy and security of many products USAMRMC develops, including human drugs, vaccines, blood products and medical devices.
"Anyone involved in the advanced development of a product needs to understand the complex regulatory process applicable to the development of that product," Kelly said, according to dcmilitary.com.
The workshop covered the process of application, appropriation of partnering agreements and intellectual property. Kelly also detailed four types of legal instruments product managers can employ to complete the process, including assistance agreements and contracts, dcmilitary.com reports.
"These agreements differ on the purpose and use of funds and the allocation of technical data rights," Kelly said, according to dcmilitary.com. "The key is to know the features and limitations of each."
The Navigating Medical Product Acquisition in the FDA classes are offered by USAMRMC's Plans, Programs, Analysis and Evaluation Directorate's Decision Gate Support Office.