The Quality Lowdown: Enforcement And Compliance During A Lingering Pandemic
US FDA oversees plants straining to meet demand for COVID-19 vaccines and treatments, while cracking down on adulterated hand sanitizers.
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Data Integrity Fallout: Sponsors Risk Reputational Damage, Negative Impacts On Other Research
US is going after fraudulent clinical trial conduct, and sponsors may be faced with determining the breadth of such fraud, whether studies will be delayed and impacts on other development programs; how a sponsor handles potential fraud could define their future interactions with FDA, DoJ.
Data Integrity: COVID-19 Impacted Studies Pose Unique Enforcement Risks
Move toward decentralized trials means sponsors may be working with naïve clinical investigators who lack experience, Greenleaf’s Cynthia Schnedar says; DoJ’s Gustav Eyler urges drug sponsors to look for oddities in clinical trial data and to voluntarily report potential misconduct.
US FDA Guidance On B. Cepacia Contamination Coming Soon, CDER Director Cavazzoni Says
Agency will provide guidance in wake of recent outbreaks of Burkholderia cepacia in non-sterile, water-based drug products.