Catherine Carr, M.S.
Responsibilities & Activities
My responsibilities include providing regulatory support for all NIDDK trials that require a regulatory application (IND/IDE/CTA) for the use of an investigational drug or device in a clinical trial. I cover all research program areas at the NIDDK, including certain intramural studies. I provide regulatory consultation to aid in the determination of the need for an IND/IDE, protocol development, study drug issues, and other regulatory matters. I work with the program officials and data coordinating centers to initiate regulatory applications, maintain applications (e.g., annual reports, protocol amendments), and assist with safety reporting for clinical trials under IND/IDE/CTA. I am also responsible for managing regulatory records.
My responsibilities also include ensuring that the Institute is in compliance with any existing or new regulatory requirements and establishing new policy to ensure compliance as well as consistency with regulatory decisions and processes across the Institute.
Committees & Working Groups
- Clinical Studies Working Group, Member
- Regulatory Gap Working Group, Chair
Senior Regulatory Health Project Manager and Senior Safety Regulatory Project Manager, Office of New Drugs and Office of Postmarket Safety, U.S. Food and Drug Administration, 2007-2010
Regulatory Affairs Specialist, DMID, NIAID, NIH, 2004-2007
Regulatory Affairs Specialist, Guilford Pharmaceuticals, 2001-2004
Biologist, NINDS, NIH, 1994-1998
M.S., University of Maryland, 1999-2002
B.S., Howard University, 1996