Orphan Drug Designation and Exclusivity for "Same Drugs"

被引:2
作者
Hong, Phebe [1 ,2 ]
Sarpatwari, Ameet [1 ]
Kesselheim, Aaron S. [1 ]
机构
[1] Harvard Med Sch, Program Regulat Therapeut & Law PORTAL, Div Pharmacoepidemiol & Pharmacoecon, Dept Med,Brigham & Womens Hosp, Boston, MA 02115 USA
[2] Harvard Law Sch, Cambridge, MA USA
关键词
D O I
10.1177/1073110519857293
中图分类号
B82 [伦理学(道德学)];
学科分类号
摘要
引用
收藏
页码:347 / 349
页数:3
相关论文
共 5 条
  • [1] FDA, ORPH DRUG DES APPR
  • [2] Food and Drug Administration, 2018, DES ORPH PROD DRUGS
  • [3] Food and Drug Administration, 2019, FDA RESP RE CERT PRO
  • [4] Food and Drug Administration, BEND PRESCR INF
  • [5] Teva Pharm, 2019, ANN REPORT FORM 10 K