FDA Waits For NDI Notifications Increase On Tail Of 'No Objection' Uptick

FDA has seen an uptick in “acknowledgement with no objection” response letters to dietary supplement firms' s NDI notifications, but says those positive responses still account for only a quarter of all its responses.

FDA entrance sign 2016

FDA is optimistic that an increase in “no objection” responses to new dietary ingredient notifications signals a positive trend, but has a more critical view of the industry's clarity about when the notifications are required and information they should contain.

The number of “acknowledgement with no objection” letters FDA has sent for NDI notifications has increased over the past two...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

Some Laid Off Employees Called Back At US FDA

 

Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.

US Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process

 

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

FDA Clears Qnovia’s NRT Inhalation IND, Commits To ‘Stimulating’ Smoking Cessation Innovation

 

Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

More from North America