What act established the guidelines for manufacturers to submit new drug applications?

The Food, Drug, and Cosmetic Act of 1938 is fundamental in the regulation of pharmaceuticals and established the framework for drug safety and efficacy. This act required that drug manufacturers submit new drug applications (NDAs) to the Food and Drug Administration (FDA) before marketing a new drug. This was a significant change from previous legislation which did not require proof of safety or effectiveness prior to a drug's sale.

The act was introduced partly in response to public health crises and is pivotal as it ensures that any new drug must be proven safe for consumption, and manufacturers must provide data regarding its efficacy and quality. This regulatory oversight helped to safeguard the public from unsafe and ineffective medications.

While the Pure Food and Drug Act of 1906 paved the way for federal regulation of food and drugs, it did not mandate pre-market approval schemes like the 1938 act. Similarly, the Drug Enforcement Administration Act is primarily concerned with the regulation of controlled substances rather than the application process for new drugs. The Prescription Drug User Fee Act, while important for the funding of the FDA's drug review process, came later and built upon the foundation established by the Food, Drug, and Cosmetic Act. Thus, the 1938 act directly aligns with the requirement for new