Yes. But so far they have only been able to file I
Post# of 72447
Posted On: 11/09/2012 12:31:45 PM
Yes. But so far they have only been able to file IND. For fast track or accelerated approval, they need to make enough progress with humans to file NDA.
http://www.fiercebiotech.com/topics/fda_approval_process.asp
New Drug Application (NDA)/ Biologics License Application (BLA)
If the drug proves to be safe and effective, the company then files an NDA or BLA with the FDA. NDAs and BLAs are typically 100,000 pages long and include results of human and animal trials as well as information on how the drug is manufactured. It usually takes the FDA 1-2 years to complete the review process and approve a drug. However, there are cases when approval can be accelerated.
- At the time of application Priority Review can be granted to drugs that treat an unmet medical need.
- Orphan Drug Status is granted to drugs that treat rare diseases, or diseases that have no other available treatments.
(0)
(0)