Cathy Burgess will speak at this conference hosted by FDLI. Her session is titled "Regulating and Mitigating Nitrosamines and Other Impurities in Drug Products." Since 2018, the presence of previously undetected carcinogenic nitrosamine impurities in a range of drug products has triggered industry-wide recalls, drug shortages, and class action lawsuits. The FDA, European Medicines Agency, and Health Canada are conducting a 3-step call for review to assess risk, conduct confirmatory testing, and implement control and mitigation strategies to prevent or reduce nitrosamine impurities. This session will discuss the status of that process, how companies should prepare for increased scrutiny surrounding the prevention and detection of nitrosamines and other impurities, and address questions on the scientific, legal, and regulatory front.
Cathy will also receive the FDLI Distinguished Service and Leadership Award. The award, established in 1993, recognizes individuals who have made notable contributions to the food and drug law community through their leadership.
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