What is the year of enactment for the Kefauver-Harris Amendment?

The year of enactment for the Kefauver-Harris Amendment is 1962. This amendment is significant because it was established in response to the thalidomide tragedy, which highlighted the need for greater drug safety regulations. Prior to this amendment, the Food and Drug Administration (FDA) primarily focused on the efficacy of drugs, but the Kefauver-Harris Amendment emphasized the requirement for drugs to be both safe and effective before reaching the market. It also mandated that drug manufacturers provide substantial evidence of drug efficacy through controlled clinical trials. This legislative change marked a pivotal moment in pharmaceutical regulation by increasing the FDA's authority, thereby improving public health protections.