US OTC Monograph Facilty Fees Increase With Pandemic-Inspired Sanitizer Makers Exempted

FDA publishes second notice on FY2021 rates for OTC monograph drug user fee program. With fewer firms paying, those still subject to facility fees will pay more so the total collected matches amount Congress authorized agency to collect, nearly $23.3m.

Businesses that began making hand sanitizers in response to the COVID-19 pandemic won’t pay US OTC drug monograph program facility fees but firms subject to the requirement will pay $6,000 more than initially was calculated.

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Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

Eisai Switches Proton Pump Inhibitor Rabeprazole To OTC In Japan

 
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Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.

German Industry Urges ECHA To Reconsider ‘De Facto’ EU Ethanol Ban

 
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Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.

AESGP: ‘No Evidence’ Of Antimicrobial Resistance With OTC Antifungals Or Antivirals

 
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Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.

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People On The Move: Appointments At Pharma Deutschland, MHRA, Futura

 
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A round-up of the latest industry moves in Europe: Pharma Deutschland elects board of new Brussels operation; MHRA's new CEO gets to work; Futura names non-executive director.

Marketplace Results After FDA OTC Monograph Overhaul Rely On OMUFA Reauthorization

 

“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.

Democrats Torch Trump’s HHS Layoffs During House Hearing On OMUFA Reauthorization

 

Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. “If we reauthorize it, will it continue?” Texas representative Lizzie Fletcher asks of OMUFA.