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US FDA’s NDIN Master File Draft Guidance Notes ‘No Presumption’ To Keep Information Confidential

 
• By Malcolm Spicer

FDA ODSP explains that whether information will be deemed a trade secret or otherwise confidential commercial information inaccessible to other firms in an NDIN master file is subject to Freedom of Information Act regulations and the relevant Food, Drug and Cosmetic Act rule.

• Source: Shutterstock

The Food and Drug Administration’s draft guidance on master files for new dietary ingredient notifications likely will boost the US dietary supplement industry’s knowledge of federal regulations on protecting trade secrets and other confidential information.

Industry stakeholders, meanwhile, agree with the FDA that allowing NDI notifiers to use master files for allowing certain other businesses...

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More from Policy & Regulation

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The agency says items on its Human Foods Program’s proposed agenda for guidance “to complete during 2025” include identity and safety information for NDI notifications. Its announcement also links to document about a separate key industry question, a rulemaking which would recognize NAC as a lawful

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