Category: Laboratories

FDA Issues Discussion Paper on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop held in 2015 regarding the oversight of LDTs. The Discussion Paper does not represent final […]

FDA hits the brakes on LDT draft guidance

Last week the Food and Drug Administration (FDA) decided to delay finalizing draft guidance for Laboratory Developed Tests (LDT).  First issued in July of 2014, the draft guidance would give FDA regulatory oversight of LDTs.  This guidance marked a significant shift in the regulation of LDT as FDA has chosen […]

Fraud Watch: Laboratory Referrals Under Government Scrutiny

Significant recent regulatory and enforcement activity related to laboratory fees and services continues to demonstrate an increased focus on this industry. Government enforcers are active in cases involving both the laboratories and physicians involved in kickback schemes. The U.S. Department of Justice (DOJ) announced in late March and early April […]