Before the FDA Approves an IND for Human Testing of a New

question 9

Multiple Choice

Before the FDA approves an IND for human testing of a new drug,

• A)several hundred volunteers have been exposed to the drug.
• B)the drug has been tested in at least two species of nonhuman animals.
• C)the drug's effectiveness has been proven.
• D)the drug must be marketed in another country.

---

Definitions:

Negative Externality

A cost imposed on third parties not involved in a transaction or activity, such as pollution from a factory affecting nearby residents’ health.

Second-Hand Smoke

The smoke inhaled involuntarily from tobacco being smoked by others, posing health risks to non-smokers.

Unemployment

The situation where individuals who are able and willing to work are not able to find employment.

Long-Term Effects

The impacts or results of a policy, action, or event that manifest or become apparent over a lengthy period.