1. Van Norman GA. Drugs, devices, and the FDA: part 1: an overview of approval processes for drugs. JACC. 2016;1(3):170–9.
2. Wecker L, Krzanowski J. The drug approval process in Japan. In: Reference module in biomedical sciences. Amsterdam: Elsevier; 2014.
3. Van Norman GA. Drugs and devices: comparison of European and U.S. approval processes. JACC. 2016;1(5):399–412.
4. Wecker L, Krzanowski J. The drug approval process in Europe. In: Reference module in biomedical sciences. Amsterdam: Elsevier; 2014.
5. Yao X, Ding J, Liu Y, Li P. The new drug conditional approval process in China: challenges and opportunities. Clin Ther. 2017;39(5):1040–51.