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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 90
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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.

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Sorry.COVID treatment data may not be reliable

World of DTC Marketing

That should tell you all you need to know about how bad things are with the FDA and trust in drug approvals. I spent a lot of time in my career working with and talking to clinical scientists about the “drug approval process” The more questions I asked the more I learned. scientists. Dr. Stephen Hahn, the F.D.A.’s

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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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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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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). The post US FDA grants Fast Track status for UNION’s oral orismilast to treat HS appeared first on Pharmaceutical 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