On Oct. 10, 1962, the Kefauver-Harris Drug Amendments were signed into law by President Kennedy.

The Legislation was passed unanimously by both houses of Congress On Oct. 2, and signed eight days later. For the first time, drug manufacturers were required to prove to FDA the effectiveness of their products before marketing them.

The new law was created in response to more than 10,000 birth defects worldwide caused by Thalidomide, a sedative used in the late 1950s.