U.S. Department of Health and Human Services

 Contact Info

Tel: 301-443-9710
Email: carrca1@niddk.nih.gov

 Select Experience

  • Senior Regulatory Health Project Manager and Senior Safety Regulatory Project ManagerOffice of New Drugs and Office of Postmarket Safety, U.S. Food and Drug Administration2007-2010
  • Regulatory Affairs SpecialistDMID, NIAID, NIH2004-2007
  • Regulatory Affairs SpecialistGuilford Pharmaceuticals2001-2004
  • BiologistNINDS, NIH1994-1998
  • M.S.University of Maryland1999-2002
  • B.S.Howard University1996

Catherine Carr, M.S.

Regulatory Program Specialist, Office of the Deputy Director

Catherine Carr, M.S.

Regulatory Program Specialist, Office of the Deputy Director
Regulatory Support Specialist​, Regulatory Support Program
Clinical Trialist, Office of the Deputy Director​​​​​​​​​​

Current 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.

Current Committee Memberships

  • Clinical Studies Working GroupMember
  • Regulatory Gap Working GroupChair