A pilot program that will see the US Food and Drug Administration and European Medicines Agency provide parallel scientific advice on complex generics and hybrid medicines to prospective applicants has been announced by the two regulators.
FDA And EMA Collaborate On Advice For Complex Generics And Hybrids
US-EU Pilot Program Will Provide Parallel Scientific Advice For Applicants
The US FDA and EMA have announced a pilot program to provide parallel scientific advice on complex generics and hybrid medicines for prospective applicants, with a goal of harmonization and increased regulatory convergence.
