Stephanie Philbin

As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more The U.S. Food and Drug Administration (FDA) recently issued General Considerations for Animal Studies Intended to Evaluate Medical Devices – Guidance for Industry and Food and Drug Administration Staff (fda.gov). Following a...more ​​​​​​​When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning....more