FDA Oversight of Laboratory-Developed Tests: Is It Necessary, and How Would It Impact Clinical Laboratories?

FDA oversight of laboratory-developed tests: is it necessary, and how would it impact clinical laboratories?

In 2010 the US Food and Drug Administration (FDA) stated that it would issue guidance on its oversight of laboratory-developed tests (LDTs), and in July of that year the FDA held a public meeting to receive feedback on a risk-based application of LDT oversight (http:// www.fda.gov/MedicalDevices/NewsEvents/Workshops Conferences/ucm212830.htm). The FDA acknowledged that LDTs have been in existen...

Edible Cannabis Products: It Is Time for FDA Oversight.

The legalization of cannabis (marijuana) for medical and recreational purposes in states throughout the United States has greatly increased its availability and use by adults and teens. Much of the earlier research on cannabis focused on its administration by smoking. Very little recent research has been conducted on the administration of cannabis by the oral route, the presumption apparently b...

Platelet Refractoriness and how it is formed

Abstract Background and Objectives Transfusion of platelet has become one of the main treatments for thrombocytopenic patients to reduce the severity and frequency of bleeding consequences. Failure to attain the desired level of platelets in a patient following platelet transfusion is defined as platelet refractoriness. The purpose of present paper is to review and study the mechanisms involve...

cpr training for nurses: how often is it necessary?

Knowledge of Laboratory Medicine in Medical Students: Is It Sufficient?

Background & Objective: Appropriate use of laboratory testing is essential for achieving safe and effective care to patient. Insufficient kno...