FDA finalizes rule on BLAs and master files

On Friday, the US Food and Drug Administration (FDA) issued a  final rule to amend its regulations concerning the use of master files for biological products.

A  master file is a submission to 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. Information contained in a master file can be used to support a submission to FDA by an applicant or sponsor.

Drug master files (DMFs) are master files that contain certain information, such as drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information, that is relevant to applications for drug products regulated under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).