What is included in the review process of a new drug application by the FDA?

The correct answer focuses on the review of safety and efficacy data, which is a critical component of the FDA's New Drug Application (NDA) process. This step involves a comprehensive evaluation of the clinical data presented by the manufacturer to ensure that the new drug is safe for human use and effective for its intended indication. The safety data includes information from clinical trials that assess the drug's potential side effects, adverse reactions, and any long-term implications of its use. Efficacy data demonstrates how well the drug performs in achieving its intended therapeutic effect compared to a placebo or existing treatments.

This rigorous review is essential to protect public health and ensure that only safe and effective medications are approved for market release. The FDA relies heavily on scientific evidence, including clinical trial results, to make informed decisions regarding drug approvals. The other options, while they may play a role in the broader context of drug marketing and healthcare economics, do not form part of the FDA's official review criteria for determining whether a new drug can be made available to the public.