FDA Regulation and Approval of Medical Device...

IgA nephropathy is a chronic kidney disease involving deposition of IgA-containing immune complexes in the glomerulus, which often causes kidney failure within 10 to 20 years. Author Michelle Marie O'Shaughnessy, MB, BCh, BAO, MS, of Galway University joins JAMA Deputy Editor Kri ...  Show more

Restless legs syndrome is a sleep-related neurologic disorder that causes an overwhelming urge to move the limbs, which can cause substantial sleep disturbance. Author John W. Winkelman, MD, PhD, of Harvard Medical School joins JAMA Deputy Editor Kristin Walter, MD, MS, to discus ...  Show more

In this episode, we speak with Janeen Winnike, the Associate Dean for Student Affairs at Rosalind Franklin and a co-course director for the Pharmacy Law course at the university. We review some of the key points regarding federal and Illinois pharmacy law – a must-listen espec ...

Description:In this episode, Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dives deep into the complexities of FDA submissions for medical devices. She sheds light on the nuances of different submission types, such as ...  Show more

Description:Dive into the enlightening world of FDA inspections with Etienne Nichols and Mike Drues. In this comprehensive episode, the duo decodes the essence of effective communication, the importance of managing expectations, and the art of proactive dialogue with the FDA. The ...  Show more

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device ...