Meds Cont.

Question 1

Center for Drug Evaluation and Research (CDER)

Answer 1

They oversee clinical trial investigations used to explore the safety and effectiveness of medications, safety devices, and medical strategies for humans.

Question 2

FDA Drug Approval Process: Step 1

Answer 2

Discovery/Preclinical testing: YEARS-6.5
TEST POP-Laboratory and animal studies
PURPOSE-Assess safety, biological activity,and formula
SUCCESS RATE- 5,000 compounds evaluated.

Question 3

Preclinical testing: What is the process?

Answer 3

This is testing in a lab, before human testing. The developer or sponsor will compile data on dosing and toxicity levels.

Question 4

Preclinical testing: when does it move on to Clinical testing?

Answer 4

Researchers will evaluate the findings to determine if the drug should move on.

Question 5

FDA Drug Approval Process: Step 2

Answer 5

The Investigational New Drug Process

Question 6

How does Step 2 work?

Question 7

How does Step 2 work?