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OTC Naproxen Labeling: US FDA Advisory Panel Finds Imprecise Direction In PRECISION

 
• By Malcolm Spicer

Safety study of celecoxib vs. ibuprofen and naproxen spurs advisory committees to recommend adding aspirin-interaction warning on OTC naproxen labels, but many panelist made clear that PRECISION results had not swayed their thinking on celecoxib CV safety or on the OTC ingredients' interaction with aspirin.

FDA Advisory Committee Feature image

A recommendation by a slim majority of US FDA advisory panel members to add label warnings for OTC naproxen's interaction with aspirin might not impress the agency after many said they weren't impressed with a trial that prompted FDA to request their help.

The Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee met in a joint meeting April 24-25 to...

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More from Regulation

More from Policy & Regulation

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
• By Michael McCaughan

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

ECHA Adds Two Cosmetic/Personal Care Silicones To REACH Candidate List

 
• By Eileen Francis

ECHA has added two silicone ingredients used in cosmetics and personal care products to the REACH Candidate List as they are persistent and have bioaccumulative properties, requiring companies to notify customers and update safety data sheets if concentrations exceed 0.1%.

Cosmetics Europe Pushes Commission To Lower Industry’s UWWTD Costs

 
• By Lauren Nardella

The European Commission plans to conduct an updated study that could reallocate extended producer responsibility costs under its Urban Wastewater Treatment Directive, a step welcomed by industry after an analysis concludes the directive vastly overestimates cosmetics’ contribution to toxic waste.