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The FDA Law Blog
FEBRUARY 22, 2023
In one way, this is good news. The draft guidance is at odds with the fundamental purpose of the 510(k) program, to enable an efficient risk-based process for FDA review and clearance of low to moderate risk devices. Accordingly, only a subset of 510(k) submissions have historically included HF validation data.
ISPE
SEPTEMBER 11, 2023
Specifically, in biopharmaceutical development, there is a continued trend of new modalities with increasing complexity and smaller batch sizes, which requires retooling traditional manufacturing approaches for those applications. These new operating models can help enable and accelerate the efforts of Pharma 4.0™
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