John Joines

John Joines is Senior Manager, Regulatory Affairs, Thermo Fisher Scientific, US.

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    Controlled substances development – past, present, and future


    Controlled substances present unique challenges and extra regulations compared to their non-controlled counterparts. Over time in Europe and the US, governing bodies have continually increased the burden on sponsors to demonstrate safety and efficacy. This includes legislation specific to controlled substances; dictating how they can be stored, destroyed, labeled, administered, ...

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    Breakthrough therapy designation: From serious diseases to opioid crisis prevention


    Following the human immunodeficiency virus crisis of the 1980s, the US Congress and US Food and Drug Administration (FDA) introduced several regulatory initiatives. The purpose was to expedite FDA review and approval of products to overcome the longer traditional pathway review timelines. One such process enabling faster approval is the ...