BARD ANGIOPLASTY PREMARKET REVIEWS SUSPENDED BY FDA UNDER FRAUD POLICY; THIRD-PARTY DATA AUDITS WILL TAKE TWO MONTHS AT MOST, COMPANY SAYS
This article was originally published in The Gray Sheet
Executive Summary
Review of pending premarket approval applications from Bard's USCI angioplasty business has been halted by FDA under the agency's data integrity policy, the company announced Jan. 19. The agency will resume the reviews when it has verified the validity of the submissions' data.