Interpreting FDA decisions on China-only data packages

FDA is cracking down on regulatory submissions for new cancer drugs tested only in China just three years after opening the door to the strategy as a way sponsors could compete on price, and its moves are leading to uncertainty in data expectations and development plans.

With recent case studies providing few hints at which combinations of drug classes and indications  — if any — may be supported by China-only data, the best course for any developer considering a China-only clinical development strategy involves clearing a plan with FDA up front, and following up regularly...