1. HBW Insight
  2. >>Wellness
  3. >>Policy & Regulation

IND Firms Contend Lax NDI Notification Enforcement Threatens Their Chances

 
• By Malcolm Spicer

Three pharma submit similar complaints to FDA's NAC docket stating the FDA isn’t sufficiently protecting their interests by allowing use of dietary ingredients similar to the drugs they’re developing.

• Source: Alamy

As far as dockets for comment on US dietary supplement regulations go, the Food and Drug Administration’s on whether the amino acid N-acetyl-L-cysteine is safe for use as a dietary ingredient wasn’t a big attention grabber, generating a low volume of responses.

For three pharma firms, on the other hand, the docket was a riveting invitation to be heard

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
Start Free Trial

Already a subscriber?

More from Regulation

More from Policy & Regulation

Digital Services Deliver Hemp, States Deliver Regulation With Congress Yet To Act

 
• By Malcolm Spicer

Four months into session, no bills have been introduced in Congress to authorize FDA to establish a regulatory pathway for the lawful use of hemp ingredients in products other than drugs or propose some other solution to the federal conundrum present since lawmakers in 2018 de-scheduled hemp.

Little Industry Opposition To FDA Plan To Remove Synthetic Dyes, Or Agreement They’re Unsafe

 
• By Malcolm Spicer

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”

Bayer Study: Self-Care Is Hardest For Those Who Need It Most

 
• By David Ridley

Being poor makes it more likely that you will suffer from self-treatable health conditions but it also means you will find it harder to take advantage of self-care solutions, finds a recently-published study by Bayer Consumer Health and IQVIA.