The process of submitting a new drug for FDA approval has 5 "steps," and takes years. Discuss one limitation of each of the following “steps” in the FDA’s drug approval process:

Preclinical research
Phase 1 Trial
Phase 2 Trial
Phase 3 Trial
"Phase 4" post-market surveillance.
(Don't define the phase. Instead, explain what limitations there are to the research associated with each step.)

Answer rating: 100% (QA)

Preclinical research Limitations Animal models do not always accurately predict how a drug will behave in humans Preclinical research is often limited ... View the full answer