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For drugs, the relevant studies are any Phase 3 study or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies). by sex, age or by genetic variations). . § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). For devices, the requirement is a bit more nuanced.
Differences in regulatory sentiments and industry sponsors’ subsequent clinicaldevelopment strategies historically restricted access based on geography. An area of interest has been deciphering ALS’s genetic underpinnings and delivering functional copies of dysfunctional genes to the patient.
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