FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.
News|Articles|September 25, 2023
Changing regulatory environment for nitrosamine impurities
Author(s)SGS Health Science
This SGS Health Science whitepaper uncovers the changing regulatory environment, and the challenges posed by the detection of nitrosamine impurities in drug products.
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