What did the Kefauver-Harris Amendment of 1961 require for new drugs?

The Kefauver-Harris Amendment of 1961 instituted significant changes in the regulation of pharmaceuticals in the United States. This amendment required that new drugs not only be safe for use but also be proven effective for their intended uses. This was a response to concerns over the safety and efficacy of medications, especially in light of the thalidomide tragedy, which highlighted the need for stronger regulations regarding drug approval.

Under this amendment, manufacturers are mandated to provide substantial evidence of a drug's efficacy through well-controlled clinical trials. Additionally, the amendment enforced compliance with current Good Manufacturing Practices (cGMP), ensuring that drugs are produced in a consistent and controlled manner. This requirement fundamentally shifted the landscape of drug approval and marketing, as it emphasized the importance of both safety and effectiveness in the therapeutic use of medications.

Therefore, the correct choice reflects these critical regulatory advancements by stating that drugs must be effective and established through current Good Manufacturing Practices. This understanding helps clarify why the other options do not accurately represent the stipulations set forth by the Kefauver-Harris Amendment. The focus was on both efficacy and safety, rather than mere safety, advertising effectiveness, or allergen content.