Type:Notice
Citation:90 FR 5892
Reading Time:about 9 minutes
The Food and Drug Administration (FDA) is establishing a public docket to gather comments about using a Type V Drug Master File (DMF) for submitting Model Master Files (MMFs) in support of Abbreviated New Drug Applications (ANDAs). MMFs contain detailed information about computer-simulated models used in drug development. The FDA is seeking feedback from the public and interested parties to improve the sharing and acceptance of these models. Comments must be submitted electronically or in writing by April 17, 2025.
Simple Explanation
The FDA wants to hear ideas from the public about a new way to share computer models used in making medicines. They're asking for opinions by April 17, 2025, to make sure everyone can help and understand this new plan better.