The FDA is holding a public hearing on November 12 and 13, 2009 from 8am to 5pm each day to discuss the increasing challenges that social media and the internet have presented to product regulation. The hearing will be at the National Transportation Safety Board Conference Center in Washington, D.C. In addition to the public meeting, the FDA will also accept comments (electronic and hard copy) until February 28, 2010.

A newly released FDA report has been made available for public comment until October 4, 2010.

Important changes are affecting the US FDA’s 510(k) process; namely the Transparency Initiative and the issuance of the 21 Draft Proposals which are now open for Public Comment.

Medical devices and IVD products able to pass muster with the US FDA and Health Canada may now enjoy de facto access to Mexico as well thanks to recent regulatory reforms. The Mexican Health Author

The US Food and Drug Administration (FDA) has proposed (Docket No. FDA–2010–N–0447) new rules targeting...

The FDA’s second-in-command Joshua Sharfstein is stepping down as principal deputy commissioner to become Maryland’s secretary of health and mental hygiene, according to

FDA regulations dictating informed consent requirements for drug and medical device clinical trials are set to change on March 7, 2012.

The US Food and Drug Administration (FDA) has recently published a draft guidance, “Electronic Source...

The US Food and Drug Administration (FDA) has rolled out some — but not all — long-awaited changes to its 510(k) premarket notification process for clearing moderate-risk medical devices.

The US Food and Drug Administration (FDA) has rolled out the 510(k) premarket notification process...