Dr. Krefting was instrumental in the approval and post-marketing safety of imaging agents such as gadolinium-based contrast agents, ultrasound contrast agents, and iodinated media. Dr. Krefting managed the regulatory approval of a new rubidium generator useful in the detection of coronary artery disease and a pharmacologic stress agent. He planned the advisory committees that provided recommendations on the safety of gadolinium-based contrast agents and ultrasound contrast agents. These advisory committees lead to significant safety labeling changes and other international regulatory actions.
Regulatory Experience
instrumental in:
Approvals & Post Marketing Safety
Regulatory Support
Regulatory Component of Product Development
from pre-IND to market – Interactions with the FDA
- Start-up support – meeting and presentation to investors
- Preparation for pre-IND meeting and Phase 1 & 2 development
- Response management to review division information requests
- Preparation for the end of Phase 2 meeting
- Phase 3 protocol development and CRO oversight
- Preparation for NDA submission
- Support over the NDA review process
- Preparation for Advisory Committees
- Development of postmarking requirement study protocols
Management of post approval safety issues
- Preparation of responses to information requests from FDA and other regulatory agencies
- Oversight of safety investigations
- Development of pharmacovigilance reports
- Guidance in safety labeling change negotiations
- Preparation for safety-related advisory committees
Imaging agents
- Application of FDA imaging guidance to specific novel agents
- Advice on the unique characteristics of imaging clinical trials
- Manage interactions with principal investigators and CROs
Education & Compliance
- Maximizing FDA and other resources for investigators and industry
- Staff training for safety and regulatory compliance
- Hiring and retention challenges
