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Opill AdCom Delay Not Unusual – Will Evaluation Of US OTC Switch Proposal Continue In The Norm?

 
• By Malcolm Spicer

Whether FDA handling of HRA Pharma’s OTC switch NDA for 0.075-mg norgestrel continues along normal arc is question which prompts concerns. “I hope that they don't make the same mistakes that were made back on the Plan B,” says Susan Wood, an associate professor at George Washington University School of Public Health and a former FDA office director.

• Source: Shutterstock

The US Food and Drug Administration’s request for additional information from the sponsor of a proposal for the country’s first OTC daily oral contraceptive wasn’t unusual as a part of the agency’s evaluation of new drug applications.

However, whether the FDA’s handling of HRA Pharma’s OTC switch NDA for 0.075-mg norgestrel, a progestin-only formulation branded Opill, continues...

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Viatris Switches Innovative Dual Action Nasal Spray In The UK

 
• By David Ridley

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

 
• By David Ridley

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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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People On The Move: Appointments At Opella, Stada, Futura

 
• By Tom Gallen

Latest European appointments: Opella names Germany director; Stada has new Western Europe head; Futura makes CEO change.

House OMUFA Reauthorization Bill Takes On Clarifying Standards For Tests To Meet GRASE

 
• By Malcolm Spicer

Health Subcommittee will discuss reauthorizing OMUFA during a hearing on how to “maintain and improve” the public health workforce and rural health as well as access to OTC medicines.

Kenvue Makes CEO Change Months After Critical Activist Investor Made Proxy Play For Board Seat

Thibaut Mongon is out as Kenvue CEO, a post he’s held since J&J spun it out in July 2023, after the firm’s results came under increased investor scrutiny over the past year. The board appointed as interim CEO Kirk Perry, a board member since December who most recently headed technology, data and pre