Home > Newsletters > International Medical Device Regulatory Monitor > Combination Products Proposed Rule Provides Streamlined GMP Option
International Medical Device Regulatory Monitor
October 2009 | Vol. 17 No. 10
Combination Products Proposed Rule Provides Streamlined GMP Option
Makers of components in co-packaged or single-entity combination products marketed in the U.S. would have two options for showing compliance with quality system (QS) requirements for devices and current good manufacturing practices (cGMPs) for drugs or biologics under a new proposed rule.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.