Gail H. Javitt

Are The Kids All Right? FDA Warning Letters Put FDA In A Bind

A Reversal On Sequencing? Proposed Legislation Would Allow Patenting Of Naturally Occurring Genes

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

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

HP&M Files Comments Opposing FDA's Proposed LDT Rule

A Question 30 Years In The Making: Would A Final LDT Rule Withstand Judicial Scrutiny?

We Have An LDT Proposed Rule!

AI/ML-enabled Medical Devices Have Everyone's Attention, Including FDA's

Proposed LDT Rule Raises Many Questions But Provides Few Answers