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) or Health Canada to provide confidential information about facilities, processes, or articles. The DMF holder can then authorize others to use the information within the DMF submission in support of … Continue reading Drug Master File Requirements