Home | Welcome to Contract Pharma   
Last Updated Friday, May 22 2015


Serious Adverse Event (SAE)

According to FDA, an adverse event associated with the use of a medical product is considered serious and should be reported to the agency when the patient outcome results in: death, life-threatening condition, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or intervention to prevent permanent impairment or damage.

blog comments powered by Disqus

Receive free Contract Pharma Direct emails
Sign up now to receive the weekly newsletter, and more!

Enter your email address:
Follow Contract Pharma On