A Drug Master File, or DMF, is a submission to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. There are four types of DMFs: Type...
Product Development
Streamlined Process for Investigational In Vitro Devices
Codeveloped with Oncology Drugs The FDA released a procedural guidance in October 2019 which provides a streamlined process for submitting investigational in vitro devices (IVD) being codeveloped with investigational drugs in the same clinical protocol. The process...