External device review pilot should await amendments to device law, NEMA says.
This article was originally published in The Gray Sheet
Executive SummaryTHIRD-PARTY DEVICE REVIEW PROGRAM SHOULD LIMIT FDA ROLE TO OVERSIGHT, Robert Britain, head of the National Electrical Manufacturers Association's diagnostic imaging and therapy systems division said at a June 19 workshop in Rockville, Maryland. "Final approval authority for new products should rest with accredited third-party reviewers, rather than with FDA itself," Britain stated.
You may also be interested in...
The European Commission has set aside, for now, concerns expressed by member states regarding the scope of medicines subjected to additional monitoring requirements.
Through its partnership with majority stakeholder Nanjing King-Friend Biochemical Pharmaceutical, Meitheal Pharmaceuticals has received FDA approval for enoxaparin, a generic rival to Lovenox.