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Enabling Clinical Trial Innovation Through AI Regulation at FDA

MedCity News

As the FDA stakes its claim as the primary regulator of AI in healthcare, it must navigate the delicate balance between fostering innovation and ensuring safety and responsibility. The post Enabling Clinical Trial Innovation Through AI Regulation at FDA appeared first on MedCity News.

FDA 317
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6 research and development life sciences predictions for 2023

pharmaphorum

Veeva’s industry experts share their predictions about how breaking down silos across clinical, regulatory, safety, and quality teams will benefit patients. Emerging and mid-sized companies launching products in Europe are also navigating a healthcare ecosystem that is complex and fragile due to regulatory and cost pressures.

Safety 111
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MHRA approves first gene therapy for infusion into the brain

European Pharmaceutical Review

The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. It has been granted marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. In addition, Upstaza reduced symptoms that can cause potentially life-threatening complications.

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Innovative biologic for myasthenia gravis granted European approval

European Pharmaceutical Review

The European Commission (EC) has now granted a marketing authorisation for biopharma company UCB’s treatment, as an add-on to standard therapy in patients who have this rare autoimmune condition. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

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Bioinfogate becomes Clarivate

Clarivate

The move further expands and integrates drug toxicity data and translational safety intelligence from OFF-X into all aspects of the life science cycle.

Safety 110
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A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

They are going to allow Biogen NINE years for follow-up clinical trials in which time our healthcare system is going to pay a TON of money for hope. The swelling was detected with the use of rigorous safety screening, including routine M.R.I.

FDA 207
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Towards ‘smart’ vaccine development and manufacturing

European Pharmaceutical Review

THE GLOBAL outbreak of the COVID-19 pandemic triggered an urgent need to protect people’s lives and livelihoods and the healthcare community recognised quite early that vaccines were the best solution to this crisis. This can drive informed decisions and strategies to enhance the safety, quality and efficiency of the manufacturing process.