A growing body of research has examined the IRA’s implications for pharmaceutical innovation. Much of this literature has focused on the potential impact on the number of new drug launches, 5, 6 but ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
In today’s Pharmaceutical Executive Daily, the FDA reportedly removes its two-study requirement for new drug approvals, Hims ...
Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...
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