The FDA wants to pull its approval of a drug. It’s not so easy.
Summary
The US Food and Drug Administration faces a complex process when attempting to reverse its approval for a medication. Agency officials previously sought guidance from an independent advisory committee to evaluate an experimental treatment for a rare autoimmune condition affecting the kidneys and lungs.
In May 2021, the US Food and Drug Administration released a lengthy briefing document on an experimental medication for a rare autoimmune form of vasculitis that often damages the kidneys and lungs. The agency was on the fence about whether to approve the treatment, and it wanted an independent advisory committee to weigh in. Among the questions at hand: Was…
Source: Read the full story at Ars Technica - All content
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