FPGEE 2026 Practice Exam for NABP – The Complete All-in-One Guide to Exam Success!

An Investigational New Drug (IND) is defined as a drug that is being tested for safety and efficacy before it receives marketing approval from the FDA. This designation is crucial because it signifies that the drug is in the clinical trial phase, where it undergoes rigorous testing to evaluate its effects on humans, determine appropriate dosages, and identify any potential side effects or risks associated with its use.

During the IND phase, manufacturers must gather sufficient data to support their application for the drug to be approved for public use. This process is vital for ensuring that any new medication is both safe and effective before it becomes available on the market.

The other options do not accurately describe an IND. A drug that is fully approved for marketing is not an IND, as it has completed all necessary testing. A drug that has been discontinued would not be in any investigational phase. Lastly, a drug sold without FDA approval is not part of the IND process, as it has not undergone the necessary trials and evaluation for safety and efficacy.