Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home Testing and CLIA Applicability.

CMS regulates clinical laboratory testing pursuant to the federal Clinical Laboratory Improvement Act (“CLIA”). Generally, a laboratory or clinical setting (such as a physician’s office) must obtain CLIA certification to perform laboratory testing. Some OTC tests, however, are approved by the Food and Drug Administration (“FDA”) for home use and the new FAQs address the use of OTC home tests in the workplace.

Continue Reading New Guidance Clarifies Requirements for Onsite Workplace COVID-19 Testing

On March 22, 2011 the U.S. Supreme Court handed down a decision which is likely to have serious repercussions for companies in the bio/pharma tech space.  In MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL., the Court rejected Matrixx argument that reports regarding the adverse effect of Zicam, its leading revenue generating product, were