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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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House Health Subcommittee Members Agree OMUFA Crucial, Split On FDA Staff Cuts’ Impact

 
• By Malcolm Spicer

Subcommittee members aren’t on same page about whether FDA staff cuts ordered by the Trump administration will prevent the agency from fulfilling its responsibilities for the OTC drug sector.

Innovations In US Hemp Market, Like States’ Regulatory Interest, More Than Skin Deep

 
• By Malcolm Spicer

Market growth and product innovations are continuing as FDA looks to Congress for authorization to establish regulatory pathway agency says it needs to determine whether to allow hemp-derived ingredients in food, dietary supplements and non-drug topicals including cosmetics.

House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

More from Policy & Regulation

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

Over The Counter: How To Balance Access And Equity In Self-Care, With Bayer’s Emese Csoke

HBW Insight speaks to Bayer Consumer Health's global strategy director for regulatory, medical, safety, quality, and compliance Emese Csoke about how least how widening access to self-care solutions can be balanced with equity with regards to affordability.