Hwang Thomas J, Darrow Jonathan J, Kesselheim Aaron S
Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts.
JAMA. 2017 Dec 5;318(21):2137-2138. doi: 10.1001/jama.2017.14896.
This study uses the Drugs@FDA database to analyze clinical development times for drugs to treat serious diseases within the 4 FDA expedited programs intended to speed drug review and approval.
本研究使用美国食品药品监督管理局(FDA)的药品数据库,分析在FDA旨在加快药物审评和批准的4个加速计划下,用于治疗严重疾病的药物的临床研发时间。