Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

F

FDA

Guest
Significant changes from the 2017 version include additional recommendations related to IRB review; informed consent, including a template; and new requirements established by the Cures Act and FDARA related to sponsors making their expanded access policies public and readily available.


Baca selengkapnya di : http://www.fda.gov...
 
Top