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clinical trials

The Role of The Falsified Medicines Directive and Delegated Regulation in The Supply Chain of Clinical Trials

Companies providing clinical trial supply services to sponsors and contract research organisations (CROs) need to comply with a complex framework of regulatory requirements and industry …

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Autoimmune Diseases

Bristol Myers Squibb’s next-gen autoimmune med starts high-stakes FDA review amid classwide JAK scrutiny

After the FDA slapped an updated safety warning on marketed oral JAK inhibitors for inflammatory diseases, market watchers have started worrying about other candidates in …

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Pediatric melanoma and the pharmaceutical
European Medicines Agency

Paediatric Melanoma and the Pharmaceutical Industry

The age of paediatric melanoma used to be a theoretical discussion, but has become a real-life challenge due to arbitrary age limits decreed by regulatory …

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