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US FDA Corrects Errors, Limits PDUFA Application Fee Increase

 
• By Derrick Gingery

Agency used a 10-year average with updated figures to calculate FY2025 PDUFA application fee and limit impact of submission volatility, but still allowed GDUFA and BsUFA fees to skyrocket.

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• Source: Shutterstock

Prescription drug application user fees, which are charged for Rx-to-OTC switch applications, will increase again in fiscal year 2025, although not as much as the previous year, while similar charges for generics and biosimilars will spike.

Key Takeaways

  • PDUFA, GDUFA and BsUFA application fees are set to increase again in FY 2025.

PDUFA fees for applications requiring clinical data will jump 6.5% to $4.31m in the upcoming fiscal year compared to FY2024.

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Viatris Switches Innovative Dual Action Nasal Spray In The UK

 
• By David Ridley

Now available without a prescription, Dymista Control is the first OTC combination treatment for consumers who are struggling to control their seasonal allergic rhinitis with a corticosteroid or antihistamine nasal spray, according to the firm.

Haleon Study: Self-Care Policies Could Save Finland €60m Per Year

 
• By David Ridley

Creating a working group to drive Rx-to-OTC switch is one of the ways in which Finland could expand self-care and save €60m per year for the country's health system, suggests a recently published report commissioned by Haleon.

PAGB: UK Gov Must Invest In Self-Care To Realize ‘Untapped Potential’

 
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EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
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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.”

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Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

 
• By Malcolm Spicer

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.

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

 
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Haleon Invests In State-Of-The-Art Oral Care R&D Facility In The UK

 
• By David Ridley

Haleon described the opening of a new oral care R&D facility in the UK as a “major investment reflecting our commitment to advancing science and innovation.”