Tuesday, April 24, 2012

CTMG, Inc. President and CEO at FDA Public Hearing

On Monday, April 23rd, Dr. Anton Usala, President and CEO of CTMG, Inc, spoke at the “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice” FDA public hearing. Dr. Usala discussed how CTMG’s designed reviewed processes, implemented under layered quality systems at the point of service delivery, ensure the most expedient path to acquire high quality data for Sponsors. Dr. Usala proposed an accelerated FDA review path for Sponsor that utilizes Physician Investigative Sites with internal, point of service quality systems. In addition, Dr. Usala’s presentation touched on the potential benefits of amending the Form 1572 in order to better allow the subject matter experts to be responsible for the organization and logistics of a study, while also making certain that the PI is aware and involved in all medical decision making.


When made available, the transcript can be viewed at the following link: http://www.fda.gov/Drugs/NewsEvents/ucm284118.htm

No comments:

Post a Comment