Removes the requirement to conduct paediatric clinical studies when the development of the medicine is not needed or is not appropriate for children
This supports resminostat's Marketing Authorisation Application in the UK
4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma CTCL, today announces that it has received a Paediatric Investigation Plan (PIP) product-specific waiver from UK Medicines & Healthcare products Regulatory Agency (MHRA) for resminostat (Kinselby), an oral maintenance treatment for advanced stage CTCL.
The regulatory processes for the registration of new medicines with the MHRA require pharmaceutical
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Kjogw Fjkavgiw (najldnzlhlr)
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