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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. FDA approves first treatment for rare paediatric genetic diseases… The post New ethical guidance for paediatric clinical trials appeared first on European Pharmaceutical Review.

Ethics 91
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Research integrity: five tips for authors, editors and reviewers

Clarivate

If the research is used to inform policy decisions around, food safety and public health, for example, then misleading and false research can risk people’s lives. Ethical publishing: an introductory course. Share your knowledge around research ethics with your peers, for example by presenting a seminar at your institution.

Ethics 105
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Canadian and US developers to trial psychedelic medicines in UK

European Pharmaceutical Review

The UK’s regulatory pathway and fast-track drug approval process enables companies to fast-track their ethics applications and combine their reviews. The regulators are the Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) respectively.

Medicine 101
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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 company stated that the designation for orismilast highlights the urgent requirement to treat HS, a chronic, inflammatory, progressive, and scarring skin disease.

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Biogen is in deep trouble and may not survive

World of DTC Marketing

According to STAT News, “acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.” No matter how you look at it, this is a major screw-up made worse by the comments of Ms.

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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Ethical leadership is essential in promoting a culture of integrity within an organisation.

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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. Highlighted in the paper is that a human-centric approach should guide all development and deployment of AI and ML.