Life Sciences & Healthcare Regulatory partner Howard Sklamberg was featured in a recent article from Insider as a "power player" for his role advising companies in the life sciences industry. Sklamberg, a former FDA deputy commissioner for global regulatory operations, discusses his work advising clients on the FDA's emergency-use-authorization protocols during the COVID-19 pandemic and his advice for industry startups.
In the feature, Sklamberg comments on the strategic role of legal counsel in helping biotech startups weigh in on FDA on policy issues while complying with federal ethics rules. Sklamberg emphasizes the need for new companies to build trust with the FDA through "the information you provide and how you operate with them."
"Because they don't have an established relationship with FDA, they don't have a reputation already with the agency," Sklamberg told Insider. "It's also about how to help them build relationships."
During his tenure at the FDA, Sklamberg directed an office of over 5,000 employees in more than 200 offices, laboratories and import facilities across the United States, Asia, Europe, and Latin America. As Deputy Commissioner, Sklamberg was FDA's top enforcement official. He oversaw the agency's inspections, enforcement, recalls, and import operations programs.
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