Corporate Counsel Business Journal Profiles Brown and Sklamberg’s FDA Practices
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Nathan Brown and Howard Sklamberg, partners in Akin Gump’s health practice, were featured in the Corporate Counsel Business Journal article “Steady Hands to Navigate the FDA’s Balance of Innovation and Safety.” The two discuss their respective practices, in which they advise clients on pre-and post-market compliance issues with the Food and Drug Administration.
Sklamberg, who spent seven years at the FDA, including in senior roles at the Office of Regulatory Affairs, now counsels clients on a range of compliance issues, drug applications and policy development. Brown, a former Special Assistant to the Chief Counsel at the FDA, focuses his practice on medical technology, including software, diagnostics and other medical devices, as well as Drug Quality and Security Act issues. Together, Brown notes, they also work with investor clients on “FDA-regulated companies and perform due diligence on transactions involving drug and device companies, labs and food facilities.”
Among the issues that Sklamberg and Brown look at in the article is whether the FDA and other worldwide regulatory authorities have kept up with digitization, advances in genetics and other technology-driven changes to the industry. Sklamberg notes that several themes “define how the FDA has dealt with all of the change over the past 10 years: more information for the public, encouraging innovation and more sources of information.” Brown adds that one of the FDA’s challenges is balancing innovation and safety.
Sklamberg and Brown also preview what to expect from the FDA under the leadership of its new Acting Commissioner. They then describe how they assist clients who are trying to deal with an evolving worldwide patchwork of food and drug safety regulation and enforcement. Sklamberg warns that, “if the FDA finds a problem with your drug manufacturing quality system, you might have a problem with not just the FDA but European regulators too,” since many companies rely on global supply chains.
To read the entire article, please click here.
