FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|October 2, 2003
- Pharmaceutical Technology-10-02-2003
- Volume 27
- Issue 10
GMP Update: Reducing Obstacles to Innovation
Author(s)Jill Wechsler
FDA offers new policies to encourage modern manufacturing approaches and automated systems, to simplify postapproval changes, and to avoid problems with sterile products.
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Articles in this issue
about 23 years ago
Designing a New Drug Packageabout 23 years ago
Filling the Void: PAT in a Connected Manufacturing Environmentabout 23 years ago
Process Analytical Technology Concepts and Principlesabout 23 years ago
October 2003about 23 years ago
Outsourcing is Front Page News in 2003about 23 years ago
October 2003about 23 years ago
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