Former FDA Advisor Eva Temkin Discusses Accelerated Drug Approval Guidance With STAT

Life Sciences & Healthcare Regulatory partner Eva Temkin was quoted in the STAT article, “Can an epilepsy drug do more than reduce seizures?” The article discussed draft guidance on the confirmatory trials that drugmakers need to conduct to receive accelerated approvals by the U.S. Food and Drug Administration (FDA).

Temkin said while the FDA is encouraging drug companies to start enrollment early on a case-by-case basis, the “real shift [the agency] is trying to emphasize in their guidance [is] that there is now going to be a presumption for all accelerated approvals, rather than this case-by-case [basis].”

Additionally, Temkin noted the draft guidance looks at how the agency’s accelerated approvals may make it more difficult to recruit patients for confirmatory trials.

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