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Sklamberg Quoted in The Pink Sheet on Remote FDA Enforcement Trends

October 7, 2021

Life Sciences & Healthcare Regulatory partner Howard Sklamberg was quoted in a recent article from The Pink Sheet, “Remote Methods Drove Most US FDA Enforcement Actions In FY 2021.” The article notes that product sampling and remote records requests accounted for most FDA enforcement actions over the past year, but foreign manufacturers faced oversight using a combination of inspections and alternate tools. Sklamberg, who held a variety of roles at the FDA from 2010 to 2017, explains that foreign over-the-counter products in particular may receive more warning letters is because of the differences in what gets evaluated and how often FDA inspections take place.

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