Pearls of Wisdom
Pearl Pathways website redesign: Guide to new features, industry insights, company history
A Guide to the New Pearl Pathways Website Welcome to the redesigned Pearl Pathways website! The site contains a lot of new content to explore, but this "guide" details some of the biggest additions and changes. A few motivations guided the development process of the...
Six-month wait no longer required for biosimilars after FDA approval
Biosimilar companies will no longer have to wait an additional six months after FDA approval to launch new biosimilars. This is due to a unanimous decision by the US Supreme Court. The case set biologics manufacturer Amgen against Novartis subsidiary and biosimilar...
Experienced medical device leader joins Pearl Pathways
Pearl Pathways proudly announces the hiring of Patti Connolly, M.S. as Director of Clinical Services. Connolly brings over 30 years of experience in medical research across academic and industry settings, with 10 years dedicated directly to product development,...
FDA Digital Health Devices Pilot Program
The commissioner of US Food and Drug Administration (FDA), Scot Gottlieb, recently announced an upcoming pilot program, which would create a third-party certification program. The program would be utilized for lower-risk digital health products allowing them to be...
FDA delays unique device identification (UDI) requirements for lower-risk medical devices
The U.S. Food & Drug Administration (FDA) announced in a letter on June 2nd its intention to extend the compliance dates for the unique device identification (UDI) system requirements for low-risk devices. Such devices include certain Class I and unclassified...