US FDA Plans Year-End Rinse Of Temporary Policy Easing Standards For OTC Sanitizer Production

FDA makes withdrawal effective on 31 December, also the deadline for firms manufacturing or compounding alcohol-based hand sanitizer products, and making alcohol for those products under temporary guidances, to cease production.

• Source: Alamy

US retailers are offering OTC hand sanitizers at discount prices due to surplus stock, the Food and Drug Administration acknowledges by planning to withdraw its temporary guidances which encouraged production by businesses auxiliary to the drug industry.

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Over The Counter: What To Expect From The 61st AESGP Annual Meeting, With Jurate Švarcaite

 
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.

Longer ACNU Rule Review Gets Kennedy Signature

 

Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.

US Monograph Facility Fees Due In Six Weeks While DOGE Subjects FDA To Rapid Changes

 

FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.

‘Nothing Unexpected’ In Third Failed Application For OTC Sildenafil In Germany

 
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“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.

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‘Nothing Unexpected’ In Third Failed Application For OTC Sildenafil In Germany

 
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“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.

‘Truly A Time Without Precedent’ Under Trump For Consumer Health Products Industry

 

“The president has chosen a do-it-all-now strategy, recognizing that the midterm congressional elections are a little over a year away,” says CHPA CEO Scott Melville. “We're just 57 days into the second Trump administration, and we are experiencing lots of unexpected things.”

AESGP Slams ‘Deeply Concerning And Discriminatory’ EU Wastewater Directive

 
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“Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation,” argues AESGP director general Jurate Švarcaite.