On Dec. 6, 2024, the FDA released draft guidance, marking a significant development in the regulatory framework for therapies approved under the Accelerated Approval Program. The 22-page guidance ...
- In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease ...
The Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint” of overall ...
“It would not be surprising to not see new FDA guidance documents issued for some period of time,” said David Larwood, CEO of Valley Fever Solutions, about the potential impact of the US Food and Drug ...
In human biology, the protein dystrophin is a shining example of Joni Mitchell’s classic line, “you don’t know what you’ve got ’til it’s gone.” Dystrophin stabilizes muscle cells. In its absence, the ...
A report showed that in cancer drug indications that received FDA accelerated approval, demonstrated high clinical benefits correlated with shorter times to subsequent full approval. Nearly a quarter ...
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