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 ...

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, ...

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 ...

A collection of transaction records. The data in transaction files is used to update the master files, which contain the data about the subjects of the organization (customers, employees, vendors, etc ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Indian companies filed 184 Type II DMFs with the US FDA in Q1 2026 against China's 149, reinforcing the country's leadership in API manufacturing and future generic drug development ...