ICTR offers expertise, resources, and consultation for investigators needing to interact with the U.S. Food and Drug Administration (FDA). Managing communications with the FDA can often be complex and daunting. Our regulatory experts specialize in helping investigators prepare for FDA interactions and submissions.
The ICTR IND/IDE Consultation Service focuses on providing assistance to researchers during the early stages of research development and maintenance of their INDs and IDEs. Our experts are well versed in regulatory strategy to include the planning, generation, and submission of various types of materials to the FDA (meeting requests, pre-meeting materials, pre-IND materials, IND/IDE applications, Annual Reports, SAE Reports, etc.).
Frequently Asked Questions:
- What kinds of consultation services are available?
- Review FDA communications and submissions [recommend consultation prior to FDA communication]
- Evaluate the need for communication with the FDA
- Provide guidance on FDA submission materials
- Prepare and strategize for pre-meeting materials
- Develop preclinical and non-clinical Study Strategies
- Assist with the generation of product development and characterization plans
- Design and implement quality systems
- Assist with assay development and qualification
- Determine IND exemption status
- Facilitate facility audits and mock FDA inspections
- Develop a vendor qualification program
- What areas does the investigator need to work on?
- Prepare paperwork and submission
- Write clinical protocol
- Prepare IRB application
- Serve as primary contact for FDA
- What costs are associated with consultation service?
- The ICTR IND/IDE Consultation Service is available to ICTR members on a fee-for-services basis (fees are based on actual hour effort commitments).
- An initial free consultation is offered to investigators to better define and assess service needs.
- How do I request a consultation?
- To learn more about this service or request assistance for your investigational product, please complete the ICTR IND/IDE Consultation Request