On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more
This client alert highlights recent regulatory developments from the Centers for Medicare & Medicaid Services (CMS) relevant to clinical laboratories. CMS is implementing or considering implementing several updates to the...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
4/1/2020
/ Clinical Laboratories ,
Clinical Laboratory Testing ,
Clinical Trials ,
Coronavirus/COVID-19 ,
EU ,
Food and Drug Administration (FDA) ,
Guidance Update ,
Infectious Diseases ,
Medical Research ,
Public Health ,
South Africa ,
UK ,
Workplace Safety
Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more
4/18/2019
/ Clinical Laboratories ,
Direct to Consumer Sales ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Human Genes ,
Laboratory Developed Tests ,
Life Sciences ,
Marketing ,
Public Health