Allyson B. Mullen

"Radical Transparency" And "Deregulation" From Trump And RFK Jr.'s FDA . . . Unless It's Useful To The Device Industry

Warning Letters: An Untapped Source For Understanding When Device Changes Require A New 510(k)

Decades Of LDT Tension Leads To An Epic Three-Hour Oral Argument

Bad Labs! Bad Labs? Whatcha Gonna Do?

One Step Closer To Final: The LDT Rule Arrives At OMB, Making A Lawsuit More Likely

FDA Issues Long-Awaited QMSR Final Rule

FDA Phones A Friend: Joint Statement With CMS Eschews CLIA Modernization And Supports FDA Oversight Of LDTs

FDA Can't Reclassify Its Way Out Of Reviewing 100,000 LDT Submissions

A Final LDT Rule In April!? Will FDA Be Prepared?

FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting