- IND Exemption Criteria
- FDA Pre-IND Consultation Program
- FDA Pre-IND Consultation Contact List
- IND Determination Request Cover Letter Template
- IND Application Package and FDA Guidance
- IND Application Template
- Initial IND Application Cover Letter
- IND Chemistry, Manufacturing and Control (CMC) Contents
- Process at FDA after IND Submission
- IND Reports and FDA Guidance
- IND Annual (Final) Report Template
- IND Annual (Final) Report Cover Letter
Expanded Access IND/Protocol
- What is Expanded Access?
- Emergency Use Expanded Access for a Single Patient
- Non-Emergency Use Expanded Access
- Online Course: Expanded Access for Treatment Use
Northwell Health employees can enroll in this course via iLearn; managers can also enroll their staff. Contact RPT@northwell.edu with any questions.
- Expanded Access Navigator
- An online tool to guide patients, caregivers and their physicians through the process for requesting single-patient expanded access for unapproved investigational drugs.
- Launched by the Reagan-Udall Foundation in collaboration with patient advocacy groups, the pharmaceutical industry, FDA, and others in the Federal government.
- Provides a directory of companies that provide information on single-patient expanded access.
- Clinical Trials Registration
Please refer to the following regulation:
The final rule does not consider any expanded access use (e.g., access under treatment INDs or treatment protocols, which provide widespread access, access for intermediate-sized patient populations, or access for individual patients) to be an applicable clinical trial.