FDA Compliance Pharmaceuticals Trials 
FDA Law Blog: Biosimilars
JANUARY 1, 2024
Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. If FDA wanted to create that impression, it likely succeeded. They have great impact on most companies that receive them.
Drug & Device Law
JANUARY 15, 2024
A fourth Justice concurred in the result, treating the issue of standards compliance in Sullivan as a matter of evidence, and holding that the lack of a sufficient trial record supporting the relevance of the specific standards at issue in Sullivan meant that the trial judge’s exclusion was not an abuse of discretion.
Expert insights. Personalized for you.
59 
Let's personalize your content