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NDI Notification Guidance Deadline Included In Senate Draft Bill For FDA User Fee Programs

 
• By Malcolm Spicer

HELP Committee Chairwoman Patty Murray, and ranking member Richard Burr also include supplement registration requirement in discussion draft for reauthorizing FDA’s user fee programs for prescription, generic and biosimilar drugs and medical devices.

• Source: Shutterstock

US dietary supplement industry stakeholders are split on the Food and Drug Administration requiring product registration as a draft Senate bill would authorize, but agreement is likely on a provision ordering the agency to publish a final guidance on new dietary ingredient notifications.

Health, Education, Labor and Pensions Committee Chairwoman Patty Murray, D-WA, and ranking member Richard Burr, R-NC, included the supplement registration...

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More from Policy & Regulation

CHPA Navigates Trump Administration’s ‘Mixed Messages,’ Ready To Traverse DSHEA Changes

 
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Some changes the administration has proposed are a “great example of regulating by press release,” says Duffy MacKay, CHPA’s dietary supplements chief. But “after 30 years, the Dietary Supplement Health and Education Act could be modernized to serve the consumer better.”

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