The US Food and Drug Administration (FDA) neither requires nor discourages the submission of Drug Master Files (DMFs). Manufacturers and DMF holders must submit separate DMFs for drug substances, excipients, and packaging materials to ensure patient privacy.
DMF holders are responsible for ensuring that their DMF satisfies all FDA requirements, including those pertaining to the Generic Drug User Fee Act (GDUFA) II and the Initial Completeness Assessment (ICA). The DMF application must be approved so that the DMF holder can issue a Letter of Access for access to other applications, such as an IND, NDA, or ANDA.
The Regulatory team at E&E Medicals is highly qualified and dedicated to their work in submitting FDA Drug Master Files (DMFs). Our staff has experience submitting and managing DMFs to the US FDA for various drug components, including drug substances, excipients, and packaging materials.
Submission strategy for various Drug Master Files to regulators, including but not limited to: