U.S. FDA Drug Master File Requirements

U.S. FDA CITATION: 21 C.F.R. ยง 314.420 (2015) Drug companies can submit a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) to provide confidential information about facilities, processes, or articles. The DMF holder can then authorize others to use the information in support of a submission to FDA without disclosing the … Continue reading U.S. FDA Drug Master File Requirements