This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs for which original NDAs and BLAs are expected to be submitted in accordance with The FDA Reauthorization Act (FDARA).
By Bob Tilling (Kallik)
By Hannah Balfour (European Pharmaceutical Review)
By Jack Garnsey (VIPRE)
By Ayal Ronen (FreeMind Group)
By Ahmed Bouzidi (ProductLife Group)