FDA Regulation and Approval of Medical Device...

Obesity affects more than 1 billion people worldwide and is recognized by the World Health Organization as a chronic, relapsing disease. WHO recently published a guideline in JAMA on the use and indications of GLP-1 therapies for the treatment of #obesity in adults. Francesca Cel ...  Afficher plus

Head and neck cancer is the seventh most common cancer worldwide and is commonly associated with tobacco and alcohol use, or human papillomavirus (HPV) infection. Author Lara Dunn, MD, of Memorial Sloan Kettering Cancer Center joins JAMA Associate Editor Margaret Wheeler, MD, to ...  Afficher plus

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 ...  Afficher plus

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 ...  Afficher plus

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 ...