Body & HealthFact

Why drugs are tested so strictly today.

Contergan (thalidomide) launched in Germany in 1957 as an over-the-counter sleeping pill. By 1961 around 10,000 children worldwide had been born with severe malformations. In the US, FDA reviewer Frances Kelsey blocked approval because the data were missing. The scandal led to strict drug-approval laws in the US in 1962 and in Germany in 1976.

Useful: Kelsey kept demanding new data for over a year – scepticism about thin evidence saves lives.

Source: en.wikipedia.org

MedizingeschichteZulassung

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