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Walking the drug regulatory tightrope

Regulatory agencies are being pulled in several directions at once, and drug developers must learn to adapt swiftly to a rapidly changing landscape.

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Figure 1: Mean times for clinical and approval phases of biopharmaceuticals over the past 20 years 7.
Figure 2: Approvals of biopharmaceuticals reviewed under standard and priority ratings from 1994 to 20027.

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Dove, A. Walking the drug regulatory tightrope. Nat Biotechnol 21, 495–498 (2003). https://doi.org/10.1038/nbt0503-495

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