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Acetaminophen Dose Labeling, More Sunscreen Information Needed, House Appropriators Tell FDA

 
• By Eileen Francis

Appropriators are "concerned that the lack of dosing information" on OTC drugs for children ages six months to 2 years "may lead to dosing errors, adverse events and inadequate treatment of fever and pain.” They also ask USDA about fraud in its National Organic Program.

Washington DC Capitol dome detail with waving american flag

The US House Appropriations Committee says dosing information for children on OTC acetaminophen product labeling is insufficient, as is the Food and Drug Administration’s outreach to consumers about sunscreen use.

In its report provided with its fiscal year 2020 spending bill for the Department of Agriculture, the FDA, Rural...

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More from Legislation

Senate HELP Committee Adds Sunscreen Regulation Overhaul To OMUFA Reauthorization

 
• By Lauren Nardella

OMUFA reauthorization bill including amendment with sunscreen regulation provisions passed by Senate committee, which also approved other provisions not included in House OMUFA bill.

Sunscreen Regulation Reforms Still Could Hitch Ride On Senate OMUFA Reauthorization Bill

As stakeholders and lawmakers pin their hopes on OMUFA reauthorization as a vehicle for enacting sunscreen regulatory changes, Senate version of the bill could be the ticket after a sunscreen-specific amendment withdrawn in the House.

Democrats Slam Trump’s ‘Sledgehammer’ On FDA

 
• By Malcolm Spicer

“We cannot ignore how Trump has taken a sledgehammer to the FDA ability to evaluate new drugs,” says California’s Nanette Diaz Barragán of California during Energy and Comme e markup discussion of five-year reauthorization of FDA’s OMUFA.

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By David Ridley

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.

More from Policy & Regulation

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
• By Derrick Gingery

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

‘Classic Economic Injury’ Merits Plaintiffs’ Standing In Challenge To US FDA Homeopathic Regulation

 
• By Malcolm Spicer

Attorney Jonathan Emord says federal court’s grant of standing for Alliance for Natural Health USA and Meditrend to challenge FDA’s safety concerns about homeopathic drugs leaves open a door to continue arguing the agency violated multiple regulations by imposing NDA requirements for homeopathics.

NDA User Fees Increasing 8.6% As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.