What should drug manufacturers demonstrate to receive FDA approval for a new product?

To receive FDA approval for a new product, drug manufacturers must demonstrate both safety and efficacy. This requirement is crucial because it ensures that the drug not only does what it is intended to do (efficacy) but also does so without causing undue harm to patients (safety). The FDA's rigorous approval process involves extensive clinical trials to provide evidence supporting these claims. Manufacturers must present data showing that the drug has the desired therapeutic effects and that it meets safety standards.

While considerations like cost-effectiveness, market demand, and therapeutic use can be important for market success and healthcare providers' decisions, they are not factors that the FDA uses as criteria for approval. The primary focus of the FDA is to protect public health by ensuring that any drug marketed is both safe for consumption and effective in treating the conditions for which it is indicated.