Medical Device Legal News with Sam Bernstein: Episode 11
On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more
The use of Artificial Intelligence (AI) tools in practice before the United States Patent and Trademark Office (USPTO) is changing how practitioners prepare and submit documents. The USPTO’s recent Guidance on Use of...more
Key Points - - New draft merger guidelines reflect the aggressive approach that has defined merger enforcement in the Biden administration, including novel theories of harm. - Proposed changes to HSR notification will make...more