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Coverage of clinical trial policy included commentary on rapid growth of the PD-1 pipeline by both US and China regulators; case studies and discussion of trial strategies including RWE, pediatric studies and decentralized trials; and US FDA commissioner-nominee Robert Califf’s R&D expertise.
A must-read selection of intriguing and popular articles posted in the Pink Sheet over the past three months.
Kite's CAR-T application seems to be sailing ahead without US FDA AdComm review; large employers in the US look into value-based contracting while European regulators band together on joint price negotiations; Teva is back at FDA with its EpiPen application. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.