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On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how ...

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 ...

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 ...

A collection of records pertaining to one of the main subjects of an information system, such as customers, employees, products and vendors. Master files contain descriptive data, such as name and ...

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 ...