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Dr. Kelsey’s Thalidomide Stand Revolutionized Drug Safety Regulations

10/23/2025

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Summary

Story summary

Dr. Frances Oldham Kelsey, a medical officer at the Food and Drug Administration (FDA) during her 45-year career, blocked thalidomide's approval in 1960 by demanding safety data, delaying its clearance.
Her actions helped spur new regulations for drug safety.
In 1962, President John F. Kennedy awarded her the Presidential Medal of Freedom for her judgment.
Kelsey retired in 2005.
She died in 2015 at age 101.

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Story summary

Dr. Frances Oldham Kelsey, a medical officer at the Food and Drug Administration (FDA) during her 45-year career, blocked thalidomide's approval in 1960 by demanding safety data, delaying its clearance.
Her actions helped spur new regulations for drug safety.
In 1962, President John F. Kennedy awarded her the Presidential Medal of Freedom for her judgment.
Kelsey retired in 2005.
She died in 2015 at age 101.