The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Last month, The Economist published a call to action titled, “There is a worrying amount of fraud in medical research: And a worrying unwillingness to do anything about it.” The article is the latest in a sequence of alarms...more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more
Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more
Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more
On March 18, 2020, the U.S. Food and Drug Administration (FDA) issued a new guidance on clinical trials of medical products during the COVID-19 pandemic, which provides general considerations to help sponsors assure the...more
The results of a Phase III study of LBEC0101, a biosimilar to Enbrel (etanercept) developed by Korean pharmaceutical company LG Chem, have been published. The study evaluated the similarities between LBEC0101 and the...more