I would like to mention about EAP program, which stands for EXPEDITED ACCESS PATHWAY. It basically to aid and benefit patients who have not met their medical need, due to criteria issues. This program provides the following:
1. It’s main purpose is to treat irreversible disease ad life threatening conditions.
2.It clears way to new upcoming technologies.
3. Increase in availability to provide patient care.
4. Formulating a solid draft of DDP.
These four items will be key considerations in determining whether or not a designation is assigned and is the reason to bring in FDA in early. The FDA then has 30 days, once the Pre-Sub is received, to provide a designation, request more information or issue a denial on the device or drug.