One Year On, US FDA Generic Drug Cluster Focuses On Facilitating Collaboration
Group Has Made Significant Progress Regarding Data Sharing
Following its inaugural year, the FDA’s Generic Drug Cluster has formed data sharing arrangements concerning a number of vital indications.
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The CEO advisory committee established by the IGBA has held its inaugural meeting and begun discussions with the director-general of the World Trade Organization to promote the “essential role” of generics and biosimilars in global health, with the interaction described as a first step towards a continuing dialog.
Leaders from a host of the world’s top generics and biosimilars companies have come together as part of a CEO advisory committee put together by the IGBA. The committee is expected to provide a forum to share thinking on key issues affecting the off-patent industry and best position the industry on critical policy issues with a single collective voice.
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.