This content was originally published on April 15, 2020. It was last updated as of Saturday, May 2, 2020 at 8:00 a.m. CST.
American universities, hospitals, and other institutions currently have a wide variety of...more
5/4/2020
/ Coronavirus/COVID-19 ,
Emergency Management Plans ,
EU Horizontal Safeguard Regulation (HSR) ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health and Safety ,
Medical Research ,
Public Health ,
Scientific Research ,
State of Emergency ,
Travel Rule
This content was originally published on April 15, 2020. It was last updated as of Tuesday, April 21, 2020 at 5:00 p.m. CST.
American universities, hospitals, and other institutions currently have a wide variety of...more
American universities, hospitals, and other institutions currently have a wide variety of healthcare, research, education, and humanitarian projects underway all over the world, with some individual universities conducting...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