This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more
9/29/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Life Sciences ,
Manufacturer Liability ,
Medical Devices ,
Medical Supplies ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Product Development Protocols ,
Research and Development
Companies need to be aware of updated guidelines issued by the U.S. Department of Justice (“DOJ”) – Criminal Division governing how the agency will evaluate corporate compliance programs. Released on June 1, 2020, the...more
On January 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a national coverage determination (“NCD”) that authorizes Medicare coverage of next-generation sequencing (“NGS”) as a diagnostic laboratory...more
2/7/2020
/ Cancer ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Diagnostic Tests ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Laboratory Developed Tests ,
Local Coverage Determination (LCD) ,
MACs ,
Medicare