Antoinette F. Konski

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

2/25/2013 - CMS Diagnostic Tests FDA Labeling Laboratory Developed Tests Marketing Personalized Medicine Pharmaceutical