File the NDA – FDA Approval Process

FDA Approval Process


If the data compiled from all three phases of the clinical trials successfully demonstrates the safety and effectiveness of the drug, the sponsor submits the New Drug Application to the FDA, requesting permission to market the drug.


The FDA conducts a thorough review of all the information supplied by the sponsor.


Once the FDA officially approves the NDA, the sponsor (manufacturer) may officially market, promote, and sell the drug.


It is important to recognize that the drug may be marketed and promoted only to treat the indication(s) which have been approved under the NDA application.