FDA safety alert procedures need better coordination, BioStar exec tells AMDM.
This article was originally published in The Gray Sheet
Executive SummaryFDA SAFETY ALERT COORDINATION WOULD BENEFIT INDUSTRY by providing a concerted agency message instead of separate communications from the Compliance and Device Evaluation offices in FDA's Center for Devices and Radiological Health, Roger Briden, BioStar director of regulatory affairs, asserted Oct. 21 at the Association of Medical Diagnostic Manufacturers annual meeting in Washington, D.C.
You may also be interested in...
New rules in India specify that a marketer of a drug will share the onus for quality and compliance along with the manufacturer. Enhanced punishment for misleading advertisements for a range of illnesses is also proposed, while calls for a statute to regulate pharma's marketing practices grow louder.
Former managing director of Janssen India to helm Bharat Serums and Vaccines following the firm’s acquisition by private equity firm Advent International.