The CTS offers regulatory support, counsel and assistance to investigators navigating FDA regulations for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.
Available services include:
- Providing a centralized resource of information and support related to addressing regulatory requirements, obligations, and responsibilities that govern the conduct of clinical research studies under investigator-sponsored INDs and IDEs
- Assisting SBU researchers in the preparation or review of initial IND or IDE applications, annual progress reports, and preparing responses to the FDA
- Ensuring appropriate institutional oversight of commitments made under investigator-sponsored INDs and IDE
- Determination of product classification (i.e., drug, device, combination product, biologic)
- Applicability of an IND or IDE.
- Assistance with submission of an IND or IDE application
- Preparation, coordination, facilitation, and attendance at FDA meetings
- Preparation for and regulatory support during FDA inspections of investigator-sponsored clinical trials
- Update regarding new guidance documents, inspection trends, inspection actions and new regulatory actions taken by FDA relating to clinical trials
Consult with an expert!
The support services are provided by IND/IDE Coordinator Suman Grewal, PhD, CCRC and Maureen Hurst, LPN, BS, MHA, CCRC.
To request an IND/IDE FDA submission consultation please use the Stony Brook CTS Consultation Request Form.docx.
For IND/IDE questions, contact Dr. Suman Grewal at Suman.email@example.com or 631-638-2056.
For Other regulatory question, contact Maureen Hurst at Maureen.firstname.lastname@example.org or 631-638-1942.