CDER-Only Reviews Increase For Combination Products With Stand-Alone Devices, But Issues Remain
Trend has emerged in last two or three years, but attorney says sponsors also have to be careful about ensuring one center maintains control of the review.
You may also be interested in...
FDA's concepts for new pathway could be ready for congressional scrutiny within a year.
Joint drug and device negotiations for combination products, separate performance goals, or maybe a separate pathway have been discussed.
New discussion draft drops controversial exclusivity extensions and some other lesser-known ideas that may have benefited FDA and sponsors, but some placeholders still need to be filled.