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FDA Finds Ingredient's IND Past After Signing Off For Supplement Use

 
• By Malcolm Spicer

Supplement industry stakeholders say FDA makes an unjustifiable regulatory move by stating that the widely used dietary supplement ingredient is noncompliant, while the finding compels the agency to reverse its earlier acceptance of NDI notifications for vinpocetine.

FDA did not object to five notifications filed in the late 1990s to use vinpocetine in dietary supplements, but the agency currently says it is not a dietary ingredient and was the subject of at least three investigational new drug from authorizations from as early as 1981.

Dietary supplement industry stakeholders say FDA takes an unjustified regulatory step by stating, without asserting a safety argument, that the...

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Some Laid Off Employees Called Back At US FDA

 
• By Sarah Karlin-Smith

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.

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• By Malcolm Spicer

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• By Malcolm Spicer

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

 
• By Eileen Francis

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

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

 
• By Eileen Francis

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.”

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

 
• By Derrick Gingery

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

 
• By Malcolm Spicer

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.