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Showing 1–4 of 4 results
Advanced filters: Author: Hubert G. M. Leufkens Clear advanced filters

  • An analysis of recent approved and failed marketing applications for new drugs evaluated by the European Medicines Agency highlights the factors that are most likely to be associated with non-approval.

    • Michelle Putzeist
    • Aukje K. Mantel-Teeuwisse
    • Hans-Georg Eichler
    Comments & Opinion
    Nature Reviews Drug Discovery
    Volume: 11, P: 903-904

  • Regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent. Here, Eichler and colleagues discuss the consequences of regulatory risk-aversion and suggest what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health.

    • Hans-Georg Eichler
    • Brigitte Bloechl-Daum
    • Guido Rasi
    Reviews
    Nature Reviews Drug Discovery
    Volume: 12, P: 907-916

  • Adaptive marketing authorization approaches may, in some instances, replace traditional binary regulatory decisions on drug approval with progressive reduction of uncertainty about the benefit–risk profile of a drug through iterative evidence gathering and evaluation. How should the nature of such evidence be determined?

    • Jean Philippe de Jong
    • Diederick E. Grobbee
    • Hubert G. M. Leufkens
    Comments & Opinion
    Nature Reviews Drug Discovery
    Volume: 12, P: 647-648