FDA Clinical Research Regulatory Actions

Medical Device Trials
Drug Trials
Biologics Trials
IRBs

There are new entries in the warning letter lists.

There is a searchable, downloadable database of FDA advice on GCP issues.
The menu item "Guidance" then "search for FDA advice" will take you to the link.

There are two databases: 1) the FDA downloadable zip files and 2) the same files
in a First Clinical database that is searchable.

If you are looking for a quick answer, use the First Clinical search link.

GCP Solutions has moved from Comcast cable internet to Verizon fiber optic internet service. This resulted in moving the web pages from the Comcast server to the Verizon server and a change in email addresses.

[last updated: November 27, 2006]