What is the primary role of the FDA in relation to New Drug Applications?

The primary role of the FDA in relation to New Drug Applications (NDAs) is to ensure the safety and efficacy of new drugs before they are marketed. This involves a rigorous review process where the FDA evaluates scientific data provided by the drug sponsor, including results from clinical trials that assess how well the drug works and its safety profile. This process is essential to protect public health, as it helps ensure that only drugs that meet the necessary standards for safety and effectiveness are made available to consumers.

The FDA does not approve all new drugs without reservation, as their role is not merely to provide approval but to conduct a thorough assessment that includes evaluating potential risks and benefits. The agency also does not regulate drug pricing; this aspect is typically influenced by a variety of market factors and policies rather than directly overseen by the FDA. Additionally, while the agency provides information about new drugs, it does not function as a promoter. Its responsibility is to ensure that comprehensive evidence supports the claims of safety and efficacy before marketing occurs. This protective role is foundational in maintaining trust and safety within the pharmaceutical market.