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
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
We’ve been talking about telehealth and mental health this week. Here’s both combined in one interesting and highly valued announcement today, followed by several tests – well, 3 million COVID tests a week to be exact, and,...more
After months of stay-at-home orders, quarantine protocols, social distancing, and back-to-school planning, the ever- present question on everyone’s mind is, When will we get back to business as usual? For many, the answer...more
In Washington: The White House moved forward with officially withdrawing the U.S. from the World Health Organization (WHO). The withdrawal would not go into effect until July 6, 2021. Sen. Foreign Affairs Committee...more
INTRODUCTION - The COVID-19 outbreak has placed an unprecedented burden on the global health care community and caused significant disruption to numerous aspects of operations, including ongoing clinical research programs....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