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Comment
. 2012 Mar;91(3):378-80.
doi: 10.1038/clpt.2011.337.

Evidence vs. access: can twenty-first-century drug regulation refine the tradeoffs?

J Woodcock  1
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Comment

Evidence vs. access: can twenty-first-century drug regulation refine the tradeoffs?

J Woodcock. Clin Pharmacol Ther. 2012 Mar.

Abstract

As the pharmaceutical industry productivity crisis worsens, there are calls for regulatory changes to support innovation. At the same time, prescribers and payers desire more information about drugs at the time they are released to the market. Will new regulatory schemes be able to accommodate these disparate needs?

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  • Adaptive licensing: taking the next step in the evolution of drug approval.
    Eichler HG, Oye K, Baird LG, Abadie E, Brown J, Drum CL, Ferguson J, Garner S, Honig P, Hukkelhoven M, Lim JC, Lim R, Lumpkin MM, Neil G, O'Rourke B, Pezalla E, Shoda D, Seyfert-Margolis V, Sigal EV, Sobotka J, Tan D, Unger TF, Hirsch G. Eichler HG, et al. Clin Pharmacol Ther. 2012 Mar;91(3):426-37. doi: 10.1038/clpt.2011.345. Epub 2012 Feb 15. Clin Pharmacol Ther. 2012. PMID: 22336591 Review.

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