The formal process in the U.S. by which this occurs is the approval by FDA of a marketing application (New Drug Application for cytotoxic/cytostatic agents or a Biologic License Application for biological agents) submitted by a private firm. The applicant seeks approval from FDA for one or more specific indication(s). Review and approval of an NDA or BLA are based on the demonstration of safety and efficacy assessed from detailed reports of the clinical trials; particularly randomized controlled studies.