Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs

On September 2, 2020, FDA published a guidance for industry entitled Control of Nitrosamine Impurities in Human Drugs. FDA reviews the guidance recommendations and industry expectations related to the steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. Additionally, FDA reviews the conditions that may introduce nitrosamine impurities and the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk for their presence.
FDA SPEAKERS
David Keire, Deputy Director, Office of Testing and Research (OTR) | Office of Pharmaceutical Quality (OPQ) | CDER | FDA
Dongmei Lu, Pharmacologist, Office of Policy for Pharmaceutical Quality (OPPQ) | OPQ | CDER | FDA
Panelists:
Deborah Johnson, Office of New Drug Products (ONDP) | OPQ | FDA
Timothy McGovern, Office of New Drugs (OND) | FDA
Andre Raw, Office of Lifecycle Drug Products (OLDP) | OPQ | FDA
Learn more at www.fda.gov/dr...
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