FDA Issues Co-Development Guidance, But Only For Products Treating "Serious" Diseases
This article was originally published in The Pink Sheet Daily
FDA Commissioner Hamburg and CDER Director Woodcock outline the requirements for developing drugs in combination during the Faster Cures Partnering for Cures meeting in New York.
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Bill proposes six months’ extra marketing exclusivity to spur development of combinations of investigational drugs for serious diseases. Setting aside prospects for passage in an election season, the question is whether that will be enough to get pharma to buy into a risky development space and pioneer a new business model.
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