A trial master file is a collection of important documents pertaining to a study, clinical trial or other form of research. Periodically, the trial master file must undergo audits to ensure the ...
FDA has developed a new set of requirements for documenting the safety of dietary supplement ingredients. Manufacturers are able to market products with new ingredients without preapproval as long as ...
On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed ...
The Food and Drug Administration (FDA) has released draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” Published this morning, this new ...
The US Food and Drug Administration (FDA) is exploring the use of model master files (MMFs) to enable sponsors to use the same modeling approach to support different generic drug development programs, ...
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