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“Adaptive Licensing” Proposals View REMS As Answer To Limited Evidence

 
• By Sue Sutter

Some ideas for new drug approval pathways seem to envision the use of Risk Evaluation and Mitigation Strategies as a means for preventing and monitoring off-label use following initial approval, apparently without regard to the seriousness or extent of a product’s risks. Given the burdens currently created by REMS, any effort to expand and retrofit the programs to a new approval pathway is likely to draw pushback from the health care community.

FDA’s Risk Evaluation and Mitigation Strategy program is being viewed as a potential tool to be used in “adaptive licensing” proposals, which suggest the risk management programs could expand from their current role of reducing serious drug risks to address products with limited evidence available at the time of initial approval.

Various ideas for new drug approval pathways, sometimes referred to as adaptive licensing or “progressive approval,” seem to look upon...

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Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

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Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

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Swissmedic Launches Pilot To Expedite Clinical Trial Applications

 
• By Anabel Costa-Ferreira

Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.

No ‘Doomsday’ For US Pharma Despite Political Uncertainties, EU Industry Chief Says

 
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