The FDA released a proposed rule to codify the use of master files for biologics applications.
The agency has informally allowed biologics sponsors to use master files — confidential, often detailed information on factories, plants or materials used to make, process, package or store drugs — as a kind of short-hand for applications that are already complicated enough. Regulators rarely review complete master files, but sponsors can refer to elements of them to support a drug application.
The FDA has been criticized for the slow pace of biologics approvals. The proposed rule would codify what had been informal, and allow biologics sponsors to submit master files for things like packaging or storage, but it wouldn’t allow sponsors to short-circuit matters such as chemistry or biology with master files.
“The risk associated with the manufacture of complex biological products is generally significantly higher than that associated with the manufacture of chemical entities, which are often less complex,” the agency says.