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UK MHRA strengthens regulations on fluoroquinolone antibiotics

Pharmaceutical Technology

The UK MHRA has introduced further restrictions on the usage of fluoroquinolone antibiotics, strengthening the previous regulations.

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Islet transplantation for type 1 diabetes: Do regulators have it right?

Pharmaceutical Technology

Diabetes researchers oppose the regulation of islet transplantation as a biologic, following the approval of CellTrans’ Lantidra.

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IRA lawsuits will test US’ ability to regulate social pricing in pharma

Pharmaceutical Technology

As the deadline nears for the government to reveal its proposed prices, pharmaceutical companies are continuing to fight regulation.

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Planning strategies for transitioning to the Clinical Trials Regulation

pharmaphorum

There is a pressing need for companies to transition their EU clinical trials that are ongoing under the “old” regulatory framework of the Clinical Trials Directive to the Clinical Trials Regulation. The risk for those that don’t meet the 30th January 2025 deadline for transition is that they will lose their legal basis.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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FDA unveils comprehensive strategy for regulating AI in medical products

BioPharma Reporter

With the pharma and healthcare landscape increasingly being shaped by artificial intelligence (AI), the US Food and Drug Administration (FDA) has taken proactive steps to outline a comprehensive strategy for regulating AI in medical products.

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Apoptosis Regulator BAX drugs in development, 2023

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Apoptosis Regulator BAX pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.