The FDA considers a medicinal substance to be a new drug under all the following circumstances except that

Question

Quizplus · Accepted Answer

A change in the name of a previously marketed brand-name product does not inherently make it a new drug under FDA regulations. The classification as a new drug is typically based on the novelty of the chemical, its safety, effectiveness, and its previous use in medical practice, not on the branding or naming of the product.

The FDA Considers a Medicinal Substance to Be a New