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Adaptive Licensing: a useful approach for drug licensing in ... - TOPRA

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The regulator’s dilemma<br />

“…it has been said that the FDA has<br />

just two speeds of [<strong>drug</strong>] approval –<br />

too fast and too slow.”<br />

Hamburg MA & Sharfste<strong>in</strong> JM. NEJM 360;24: 2493-5; 2009<br />

6

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