Question

The "treatment use" of investigational drugs usually occurs at which stage of drug testing? A. During FDA review of a new drug application (NDA) B. During long-term animal toxicity testing C. During Phase 1 clinical testing D. During FDA review of the investigational new drug application

Answer 1

The "treatment use" of investigational drugs usually occurs during FDA review of a new drug application (NDA). Correct answer: A

During the NDA FDA approves a new pharmaceutical for sale and marketing in the U.S. The process should confirm that the drug is safe and effective in its proposed use(s), that the benefits of the drug outweigh the risks, that the drug has appropriate labeling and is manufactured through adequate manufacturing methods.