Event
FDA review of thalidomide (1960)
The FDA's review of the thalidomide application, in which medical officer Frances Kelsey withheld approval for lack of evidence.
- Dates
- 1960–1962
Connections 4
involved
- Frances Oldham Kelsey reviewer who refused to approve the application Primary record 1
- U.S. Food and Drug Administration Primary record 1
- Thalidomide Primary record 1
led to
- Drug Amendments of 1962 Primary record 1
Timeline 1 date
- 1960–1962 FDA review of thalidomide (1960)
Proof 1 source
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Frances Oldham Kelsey: Medical reviewer famous for averting a public health tragedy, U.S. Food and Drug Administration.
Primary record
Dr. Kelsey, despite constant pressure from the company, refused to approve the application because of its inadequate evidence.
The drug was never marketed in the U. S.
One of the first applications she was assigned was for thalidomide, which was already available in dozens of countries around the world.
Approximately a year later researchers in Germany and Australia linked thalidomide to clusters of rare, severe birth defects
the impact of the near disaster here helped to pass a pending bill that fundamentally changed drug regulation, the 1962 Drug Amendments
Page history 1 change
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