Legal Use Case 7: A Conversation
Legal Use Case 7 Part II: The Prescription
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more
This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more
On February 19, 2013, FDA issued a supplemental notice of proposed rulemaking in the Federal Register, re-proposing amendments regarding information about pediatric subpopulations that must be submitted for certain medical...more