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UK’s MHRA To Offer Private Meetings For Innovative RWE Strategies

 
• By Eliza Slawther

The MHRA’s new scientific dialog program will offer drug developers “closed-door meetings” that will offer “confidential, commercially sensitive discussion” with its staff to help them “refine” their real-world evidence generation strategies.

A new real-world evidence (RWE) program, set to be launched by the UK’s Medicines and Healthcare products Regulatory Agency, will see innovative drug developers benefit from private meetings with representatives from the agency and England’s health technology assessment (HTA) body, NICE.

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Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
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German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 
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Ad/Promo: Improved Adherence Claim For Dexcel’s Hemady Not Supported, US FDA Says

 
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A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.

More from United Kingdom

Trump’s Tariffs Will Lead To ‘Instability’ And ‘Less Investment’ In UK

 
• By Eliza Slawther

While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.

UK Health Secretary Admits VPAG ‘More Expensive’ Than Expected & Needs To Be ‘Resolved’

 
• By Eliza Slawther

The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.

AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE

 
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England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.