Conditional early approval for new drug applications in Japan: Current and emerging issues

Clin Transl Sci. 2023 Aug;16(8):1289-1293. doi: 10.1111/cts.13536. Epub 2023 May 10.

Authors

Mototsugu Tanaka¹, Haruna Miyazawa¹, Ryohei Terashima¹, Mutsuhiro Ikuma²

Affiliations

¹ Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan.
² Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

No abstract available

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Drug Approval*
Humans
Japan