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ABOUT THIS WEBINAR

On September 2, 2020, FDA published a guidance for industry entitled Control of Nitrosamine Impurities in Human Drugs. FDA will review 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 will review 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.

Topics Covered

• Background on Nitrosamines Impurities
• Recommendations to Industry
• Reporting Changes to FDA

INTENDED AUDIENCE

• US and international manufacturers of human drugs for the US market, including manufacturers of prescription and over-the-counter drug products and manufacturers of active pharmaceutical ingredients
• Regulatory affairs professionals working on OTC drugs, compounded products, NDA and ANDA submissions, as well as active pharmaceutical ingredient Drug Master File holders
• Consultants focused on drug manufacturing and quality assurance

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

FDA RESOURCES

• Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
• Submit comments online
• Information about Nitrosamine Impurities in Medications