US FDA And EMA Officials Work To Boost Interest In Parallel Scientific Advice Program
Executive Summary
Timeline and predictability concerns aren’t supported by recent data, officials argued, but questions may linger about the eligibility of products with device components.
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.
Joint Inspections and Parallel Scientific Advice: Same Weaknesses?
The EU and the US regulatory bodies will have to work hard if their planned joint inspections pilot programme is to be more successful than their efforts to provide joint parallel scientific advice, says Fabien Roy.
Parallel Advice: A False Step in March to Globalized New Drug Reviews?
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.