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Codeine Concerns Cough Up FDA's OTC Monograph Problems

 
• By Malcolm Spicer

Pew Charitable Trusts joins CHPA, medical groups in urging Congress to authorize moving the US monograph system to an administrative process and to authorize a monograph user fee program.

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FDA recently ordered label changes for Rx codeine drugs but could do nothing immediately and directly to affect marketing of OTC monograph drugs containing the ingredient. This disconnect provides more evidence that FDA should be empowered with flexibility to address these kinds of situations, as it can for prescription drugs, consumer health industry stakeholders say.

Additionally, the Pew Charitable Trusts suggests the case is clearly made for establishing user fees to support FDA’s work in determining whether drug ingredients are safe and effective for a monograph indication by the big

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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.

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

 
• By Malcolm Spicer

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

 
• By Malcolm Spicer

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

 
• 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.”

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