About
The Drug and Device Regulatory Assistance Program offers comprehensive support to researchers navigating the complex landscape of FDA regulations. Our experienced team provides tailored guidance and assistance throughout the research process, from early-stage development to clinical trials and considerations for commercialization.
Support offered:
- Regulatory Consultations: One-on-one consultations with experienced regulatory experts to help you understand FDA requirements and identify the appropriate regulatory pathway for your research.
- Protocol Review: Assistance reviewing research protocols to ensure compliance with FDA guidelines and IRB requirements.
- IRB Submission Support: Guidance and support in addressing FDA requirements in preparation of IRB submission and addressing any questions or concerns raised by the IRB.
- FDA Submission Preparation: Assistance in preparing and submitting regulatory documents to the FDA, including pre-submission and meeting requests, INDs, and IDEs.
- Regulatory Compliance: Ongoing support to ensure compliance with FDA regulations throughout the research process.
Target audience:
- Investigators new to FDA-related research
- Researchers with complex research projects that require additional regulatory guidance
- Faculty and staff involved in drug or device development
Related support elsewhere on campus:
FDA Regulated Research Oversight Program: Access campus-wide policies applicable to FDA regulated research studies, training opportunities, and FDA related guidance documents.
Central Monitoring Service (CMS): Investigators may contract with CMS to monitor the progress of FDA-regulated trials and verify that the study is conducted in accordance with applicable regulatory requirements
