Understanding The RTF Letter

By Hugh Donovan, Managing Expert, Advarra Clinical Center of Excellence

The development of new treatments, both drugs and biologics, is a long and arduous process, which can take many years. After the preclinical and clinical programs are successfully completed, the company makes a submission to the U.S. Food & Drug Administration (FDA). The subsequent FDA review, if everything has been done correctly, and the efficacy and safety data are supportive, can be completed within six to twelve months. Read about the two major obstacles to getting approval and market authorization.