After years of FDA discussion and failed congressional efforts to assert greater oversight of laboratory developed tests (LDTs), FDA has proposed a rule that would require many LDTs to comply with FDA’s requirements for in...more
The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more
9/25/2023
/ Biologics ,
Coronavirus/COVID-19 ,
False Statements ,
Food and Drug Administration (FDA) ,
Fraud ,
Inspections ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Public Health ,
Warning Letters
As companies begin planning for the upcoming year, attorneys who sit on promotional review committees should consider the significant guidance published by the U.S. Food and Drug Administration (“FDA”) and update process aids...more