Michelle Tarver, director of the Center for Devices and Radiological Health, and other center officials attended virtually as a government shutdown continues.
Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two ...
FDA continues essential operations during the funding lapse, focusing on public health safety while halting new drug applications and submissions.
At AdvaMed’s annual conference, CEO Scott Whitaker addressed policy issues around tariffs, FDA staff cuts and the ongoing ...
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 ...
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 ...
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