Sklamberg Discusses FDA’s Parallel Scientific Advice Program

Howard Sklamberg, Life Sciences & Healthcare Regulatory partner and former FDA Deputy Commissioner, was quoted in the recent Law360 article, “FDA Defends European Pilot Program, Seeks More Applicants.” The articles discussed the U.S. Food and Drug Administration’s (FDA) Parallel Scientific Advice pilot program and a recent request from the agency for applicants working on complex generic drugs consider using the program.

Sklamberg told Law360 that the FDA’s recent call may cause some to reconsider the program, which was launched in 2021 with the aim of helping the FDA and the European Medicines Agency align their thinking on certain medicines. "The idea of coordinating the approval process with Europe has been a longstanding FDA goal," Sklamberg said. "The FDA itself does a lot of scientific exchanges with the European Medicines Agency and European regulators."

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