News & Events

FDA Warning Letter

Please read: FDA Warning Letter  Read More >>

FDA Finalizes a Streamlined Option for Physicians to Request Individual Patient Expanded Access for Use of an Investigational New Drug or Biologic

FDA Issues Guidance Related to Expanded Access Read More >>

New Medical Device Education Modules

New Medical Device Education Modules  Read More >>

Draft Guidance: Investigational New Drug Applications Prepared and Submitted by Sponsor-investigators

New FDA Draft Guidance issued May 2015 Read More >>