With trial waivers India moots PMS norms for anticancers
This article was originally published in Scrip
India's apex committee for regulating clinical trials has endorsed trial waivers for five products, including the anticancer enzalutamide ( Astellas/Medivation's Xtandi), the hepatitis C treatment sofosbuvir and MDR-TB drug bedaquiline, albeit with conditions attached in certain cases.
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