www.fdanews.com/articles/138580-drug-dx-makers-want-more-detail-in-companion-ivd-draft-guidance
Drug, Dx Makers Want More Detail in Companion IVD Draft Guidance
July 22, 2011
Device companies and drugmakers will need to work closely and quickly to ensure that novel therapeutic products and their companion in vitro diagnostic devices are ready for FDA review at the same time, a draft guidance says.
Devices & Diagnostics Letter
Devices & Diagnostics Letter