The risks associated with the growth of AI in the healthcare and life sciences industries, as well as recent federal and state activity and enforcement actions, emphasize the importance of understanding and implementing a...more
Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding requirements for device...more
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition...more