Tag Archives: oversight

FDA moving to 'risk-based' inspections even as valsartan scare adds new wrinkle to oversight

FDA inspections of generic drug plants are on the rise and should continue to increase through 2019, Commissioner Scott Gottlieb said this week in a series of tweets.  But the game has changed, Gottlieb pointed out, with the number of pre-approval inspections growing more than surveillance inspections, in part to approve more generics in an effort… Read More »

Digital transformation demands a whole new level oversight to avoid healthcare fraud

The federal government estimates that over $ 36 billion in improper fee-for-service Medicare payments have been racked up and the industry overall is wrought with fraud and abuse. Part of it is the nature of the business, said Paul H. Westfall, Washington Counsel for the American Medical Association.  It’s a very high-transaction and high-volume sector… Read More »