What is a DMF?
Ans- A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Important facts regarding DMFs
It is submitted to FDA to provide confidential information. Its submission is not required by law or regulations. It is neither approved nor disapproved
It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these. It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420. It is not required when applicant references its own information.
Ans- A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Important facts regarding DMFs
It is submitted to FDA to provide confidential information. Its submission is not required by law or regulations. It is neither approved nor disapproved
It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these. It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420. It is not required when applicant references its own information.
