Blog Detail
Carl's Blog on FDA Stuff
http://carl1anderson.wordpress.com/
A former FDA employee comments on FDA related news, in particular clinical trials and the regulation of drugs and medical devices.
- Added on: Mar 7th, 2009
- Country: United States
- Language: English
- Author: Carl Anderson
- Listed in: Health Law & Legal
- Tags: clinical trials fda glp research ethics gcp clinical qa
Recent Posts
Happy Holidays
The Blogster is off to Arizona for a bit to have some holiday cheer and go hiking in the Rincon Mountains. I wish everyone out there in the blogosphere the best of all possible holidays. CHEERS !!! ...
NIDPOE: An FDA Warning Letter on Steroids
It doesn’t happen very often but for the fourth time this year FDA has issued a NIDPOE letter, Notice of Intitiation of Disqualification Proceedings and Providing Opportunity to Explain. This is only for the most serious breaches of FDA regulat...
Another IRB, Another FDA Warning Letter
FDA is keeping up its scrutiny of Institutional Review Boards with a Warning Letter to the Burzynski Research Institute IRB. This is a publicly traded, for profit company who decided to run their own IRB and dispense with the formalities, and expense...
FDA Hits ICON with Warning Letter for J & J Studies
FDA posted a new Warning Letter on its website to ICON Clinical Research, the CRO responsible for many of the activities that led to the Johnson & Johnson sponsor Warning Letter last August (see previous posts). The heavily redacted document list...
More on the “artificial pancreas” at Diabetes Technology Conference
Here is a link to the Applied Clinical Trials online edition for an article written, by the Blogster, on the Diabetes Technology Conference and the “artificial pancreas.” ACT has a new feature on clinical trials for diabetes and other the...
Centra & Teneo IRBs Receive FDA Warning Letters
OK, I said that I was going to take a break until New Year’s. However, the letter to the Teneo IRB is an interesting FDA Warning Letter for several reasons. First, the Center for Biologics, FDA’s smallest for human clinical trial regulati...
