Final answer:
A New Drug, per the FDCA, goes through rigorous evaluation and approval processes, including laboratory and clinical trials, to ensure its safety and effectiveness before it can be FDA approved and marketed to the public.
Step-by-step explanation:
Per the Federal Food, Drug, and Cosmetic Act (FDCA), a New Drug is one that has not been previously recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of the drug, and that has not been used to a material extent or for a material time under such conditions. The Center for Drug Evaluation and Research (CDER) requires New Drugs to go through a stringent approval process known as a New Drug Application (NDA). This involves compiling substantial laboratory data, including data from animal trials, and if those are promising, submitting an Investigational New Drug (IND) application to the FDA. Upon review and a 30-day waiting period, clinical trials may begin, providing human subject data on the effectiveness and safety of the drug, including side effects. Only after meeting the FDA's high standards for efficacy and safety can the developers submit an NDA, detailing the drug's manufacturing, packaging, monitoring, and administration processes to secure FDA approval, with safety for consumer use as a critical emphasis.