What happens during the process of drug approval by the FDA?

During the process of drug approval by the FDA, the focus is heavily on clinical studies, trials, doses, and concentrations. This rigorous evaluation is essential to ensure that the medication is both safe and effective for public use.

Clinical studies involve testing the drug on human subjects under controlled conditions to assess how it performs in real-world scenarios. These trials are designed to provide data regarding the drug's efficacy—how well it works to treat a condition—as well as its safety profile, which includes potential side effects and contraindications.

The evaluation also extends to the appropriate doses and concentrations of the drug, as these factors significantly influence the drug's therapeutic effects and the risk of adverse reactions. This thorough review process helps the FDA determine whether a drug meets the necessary standards for public approval and use.

In contrast, evaluating only the cost, surveying public opinions, or discussing marketing strategies do not form part of the primary scientific assessment required for drug approval. While these factors might come into play later in the commercialization phase, they do not influence the critical evaluation of the drug's safety and efficacy that is the core focus during the FDA's approval process.