According to the Food, Drug, and Cosmetic Act of 1938, what is required before marketing new drugs?

The requirement for proven safety before marketing new drugs is a fundamental component of the Food, Drug, and Cosmetic Act of 1938. This legislation was a critical step in ensuring that drugs are safe for consumption before they can be marketed to the public.

The law established a framework for drug approval that mandates manufacturers to submit evidence demonstrating the safety of their products through clinical trials and other studies. This process ensures that any potential risks are identified and assessed, thereby protecting public health and safety.

While other options touch on aspects related to the drug approval process, such as manufacturer involvement and broader regulatory considerations, they do not directly capture the primary requirement set forth by the Act, which emphasizes the necessity for drugs to be proven safe before they can be sold. This focus on safety laid the groundwork for the rigorous standards we see in the drug approval processes today.