FDA Publishes Drug Master File Guidance
The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.
FDA announced the publication of draft guidance on drug master files on October 18, 2019. The new guidance revises the agency’s September 1989 guidance, Drug Master Files: Guidelines and details the preparation and submission of drug master files (DMFs).
DMFs are submissions to FDA that provide “confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.” DMFs may also contain toxicology information and shared system risk evaluation and mitigation strategies. DMFs may be used to support new drug applications, abbreviated new drug applications, and investigational new drug applications. They may also support biologics license applications under the Public Health Service Act. DMFs themselves are not approved by FDA but the technical contents of DMFs may be reviewed in connection with the applications that reference them, according to the agency.
The new guidance discusses the types of DMFs, how to submit DMFs including format and delivery, and how to report changes to DMFs. The guidance also details FDA review processes including administrative review and technical review.
Source: FDA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
