Which act was established in 1962 to strengthen the drug approval process?

The Kefauver-Harris Amendment, established in 1962, was a significant piece of legislation that strengthened the process of drug approval in the United States. This amendment emerged in response to the thalidomide tragedy, where a drug caused severe birth defects, highlighting the need for stricter regulations surrounding drug efficacy and safety.

Before this amendment, the Food, Drug, and Cosmetic Act primarily focused on the safety of drugs, but the Kefauver-Harris Amendment introduced requirements for pharmaceutical companies to provide evidence not only of safety but also of effectiveness before a drug could be marketed. It mandated that drugs had to be proven effective for their intended use and established more rigorous standards for clinical testing, requiring pharmaceutical manufacturers to submit more detailed information regarding the drug's composition, effects, and any potential adverse reactions.

The amendment also enhanced the FDA's authority to regulate the marketing of drugs and established a greater emphasis on post-marketing surveillance to monitor drug safety after approval. This comprehensive approach helped to ensure that the medications available to the public were both safe and effective, greatly contributing to public health and consumer protection.

In contrast, the other options refer to different aspects of drug regulation. The Food, Drug, and Cosmetic Act was the precursor legislation to the Kefau