Eva Temkin Talks FDA ‘Expert’ Panels in STAT

Eva Temkin, Life Sciences & Healthcare Regulatory partner and former Acting Policy Staff Director at the FDA’s Office of Therapeutic Biologics and Biosimilars, was recently quoted in the STAT article, “SSRI drugs, pregnancy, and depression: What to know about FDA panel,” which reports on a recent discussion hosted by the Food and Drug Administration about the effects of selective serotonin reuptake inhibitors (SSRIs) during pregnancy.

Temkin explained that this kind of “expert” panel — the latest in a series at the FDA — is unconventional in the way that it was convened and held.

“Ordinarily [the panels] would be catalyzed by some sort of new information that raises questions,” Temkin told STAT. “By new information, I mean new scientific information, not new politics.”

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