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New ethical guidance for paediatric clinical trials

European Pharmaceutical Review

The US Food and Drug Administration (FDA) have published initial guidance deliberating how ethical it is for children to take part in research trials. Thus, numerous drugs and medical devices approved and licensed by the FDA are missing essential paediatric-specific information on their product labels.

Ethics 91
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EMA seeks public opinion on AI in drug development

European Pharmaceutical Review

The US Food and Drug Administration (FDA) published its discussion paper on AI in drug development in May 2023, and now European regulators following a similar route to help chart a new course for this emerging technology.

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Canadian and US developers to trial psychedelic medicines in UK

European Pharmaceutical Review

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

Medicine 100
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Biogen is in deep trouble and may not survive

World of DTC Marketing

SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.

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Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. The post Why Is FDA Issuing Fewer Marketing Violation Letters?

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US FDA grants Fast Track status for UNION’s oral orismilast to treat HS

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast Track designation for UNION therapeutics’ oral orismilast to treat moderate-to-severe hidradenitis suppurativa (HS). Orismilast, a PDE4 inhibitor, targets the PDE4 subtypes which are connected to inflammation.

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). Tuijin Jishu / Propuls. 2023; 44(3):1384-1392. cited 2023Dec]. Machine Learning in Medicine.