FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|April 2, 2003
- Pharmaceutical Technology-04-02-2003
- Volume 27
- Issue 4
Overhauling Compliance and GMPs
Author(s)Jill Wechsler
FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.
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