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The European Union is in the middle of revising its medicines legislation. This reform, often referred to as the “pharma package,” centers on a proposed new Pharmaceutical Regulation and a proposed new Pharmaceutical Directive. Its stated…
Drug companies typically seek a formal labeling change from the U.S. Food and Drug Administration (FDA), or a parallel regulatory body outside the U.S., to market a drug for a new use.
This summer, the Center for Advanced Studies in Bioscience Innovation Law (CeBIL) at University of Copenhagen assumed stewardship and maintenance of the Patent Pledge Database created by Professor Jorge Contreras.
Transparency rules in clinical trials attempt to strike a balance between ensuring essential safety and efficacy data reaches the public, and preserving truly proprietary information that fosters innovation.
