Lecture 4

Question 1

What is the fda

Answer 1

Agency within the Department of Health and human services. protects public health through approval of human and veterinarian drugs, biological, foods and cosmetics

Question 2

CDER

Answer 2

Center for drug evaluation and research, part of fda. Reviews IND for drugs and market approval applications. Post market monitoring

Question 3

CBER

Answer 3

Center for biologics evaluation and research, part of FDA. Evaluates IND for biological and market approval applications. Post market approval monitoring

Question 4

Title 21 CFR

Answer 4

Code of federal regulations pertaining to food and drugs. Enforced by law and published by the federal government

Question 5

Subject definition

Answer 5

Person who participates in a clinical trial can receive investigational drug or placebo, can be healthy or with disease

Question 6

FDA regulations for running clinical trials under 21 CFR (8)

Answer 6

Electronic records and signatures, protection oh human subjects, financial disclosure of clinical investigator, GLP for nonclinical studies, IRB, drug labeling , IND, application for FDA market approval of new drug