Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two ...

Michelle Tarver, director of the Center for Devices and Radiological Health, and other center officials attended virtually as a government shutdown continues.

At AdvaMed’s annual conference, CEO Scott Whitaker addressed policy issues around tariffs, FDA staff cuts and the ongoing ...

FDA continues essential operations during the funding lapse, focusing on public health safety while halting new drug applications and submissions.

Scott Whitaker, AdvaMed CEO and president, spoke about working with the Trump administration to maintain medtech gains.

FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — Food and Drug ...

The U.S. FDA device center’s guidance agenda for fiscal 2026 is the classic case of something old and something new, but what ...

The U.S. Food and Drug Administration said on Friday it has launched a new pilot program to speed up the review process for ...