STAT Interviews Former FDA Official Eva Temkin on Proposed Reduction in Clinical Trial Requirements

Eva Temkin, Arnold & Porter Life Sciences & Healthcare Regulatory partner and former Acting Policy Staff Director at the U.S. Food and Drug Administration (FDA)’s Office of Therapeutic Biologics and Biosimilars, was recently interviewed for the STAT article, “FDA to lower number of trials required for approval of drugs, other medical products,” which covered the agency’s plan to require one clinical trial, rather than two, as the default standard for considering approval of drugs and certain medical products.

Eva explained that existing law grants the FDA significant flexibility in evaluating evidence of safety and efficacy. She noted that the current framework already allows the agency to rely on one adequate and well-controlled trial, together with confirmatory evidence, and suggested that the law may permit the FDA to make that approach the default standard.

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