News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

FDA Warns Genentech (RHHBY) Trial Investigator Over Data Problems


7/17/2013 7:17:52 AM

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

An investigator for a Phase III trial for the Lucentis macular degeneration treatment, which is sold by Genentech, has received a warning letter from the FDA for failing to follow the protocol and maintain accurate case histories of patients. And his omissions and mistakes raised concerns about the “validity, reliability and integrity of the data” that was captured at his site, according to the FDA letter. The physician, Bernard Doft, participated in the HARBOR study that compared low and high dose versions of Lucentis among patients with the eye affliction, which is a common affliction among the elderly.

Help employers find you! Check out all the jobs and post your resume.

Read at Pharmalot


comments powered by Disqus
Pharmalot
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES