All drugs have to follow the same path to approval at the US Food and Drug Administration, except when they don’t. Today, with the support of NIHCM, we’re learning about the exceptions to the rules that can happen when drugs get approved. The FDA has several alternate pathways that can help drugs get to patients more quickly. As usual, the world is complicated, and there are upsides and downsides to these exceptional circumstances.
Related HCT episodes:
Aduhelm and FDA Approval:
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