Post by
cheetio on Nov 13, 2014 6:18pm
1-2
ye awe come back now...hear 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.
Comment by
txbioinv on Nov 13, 2014 10:45pm
cherrios,, can you call Mr FDA and inquire how many chimps had bladder cancer? please ask how many months past 24 for approval while your at it? soft basher........