Parallel Advice: A False Step in March to Globalized New Drug Reviews?
This article was originally published in RPM Report
Executive Summary
Few manufacturers are taking advantage of a program under which FDA and European regulators work together to provide scientific advice to drug developers. Now the agency is wondering whether it should end the program.
You may also be interested in...
FDA-EMA Pilot Could Further Push Global Generic Harmonization, But Will Sponsors Use It?
Regulators hope parallel scientific advice pilot for complex generics is more popular than brand program was at start; sponsors want use of foreign comparator products and tighter harmonization.
FDA-EMA Pilot Could Further Push Global Generic Harmonization, But Will Sponsors Use It?
Regulators hope parallel scientific advice pilot for complex generics is more popular than brand program was at start; sponsors want use of foreign comparator products and tighter harmonization.
FDA-CMS Parallel Reviews: Too Close for Comfort?
Parallel reviews by FDA and CMS are back on the table. While the proposed voluntary program seems harmless enough, drug and biotech companies may have good reason to be wary of greater collaboration between FDA and CMS officials.