Switching Can Help Normalize Self-Care – PAGB’s Michelle Riddalls
Automatic switch from pharmacy to general sales list status and leveraging the power of real-world data are two ways in which the UK's switch system can be made more efficient, according to the PAGB's new senior director of Regulatory Affairs, Michelle Riddalls.
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Reps. Latta, Crenshaw and Miller-Meeks contend language in ACNU final rule preamble would allow a sponsor of an approved application to litigate to halt Rx availability of same formulation and “risk eliminating the very rule on which its product approval was based.”
HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.
“I’m not sure exactly if they understood how broad this actually is and what that might potentially lead to or what the follow-up would be if somebody now decides to sell a 10-milligram version of ivermectin for human use,” says food and drug regulation attorney Frederick Stearns.
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.
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The US launch of Eroxon ED treatment by Haleon helped Futura Medical record its first ever profit in 2024. The UK firm will now look to capitalize this by seeking US and EU approval for a more potent Eroxon line extension.
Reps. Latta, Crenshaw and Miller-Meeks contend language in ACNU final rule preamble would allow a sponsor of an approved application to litigate to halt Rx availability of same formulation and “risk eliminating the very rule on which its product approval was based.”
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