EU Drug Repurposing Pilot Kicks Off
Industry Welcomes Project, With Caveats
A new European initiative will offer scientific advice, fee waivers and other support to not-for-profit and academic sponsors to help them find new uses for existing medicines and hook up with commercial companies to seek marketing authorization.
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The coordination group for EU mutual recognition and decentralized procedures is inviting stakeholder feedback on its priorities for the coming years.
Licensing new uses of existing medicines has several benefits over off-label use, such as offering assurances that the indication is evidence based and subject to an ongoing safety monitoring program, according to a new report.
In an exclusive interview with the Pink Sheet, the European Medicines Agency’s Tony Humphreys explains the thinking behind the agency’s regulatory science strategy, why the PRIME scheme is to get a boost – and why the need to tackle health threats ranked so low in a stakeholder consultation.