Exam 1 FDA Pregnancy Categories

Question 1

What FDA pregnancy category is this?

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters)

Answer 1

Pregnancy Category A

Question 2

What FDA pregnancy category is this?

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Answer 2

Pregnancy Category C

Question 3

What FDA pregnancy category is this?

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Answer 3

Pregnancy Category B

Question 4

What FDA pregnancy category is this?

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Answer 4

Pregnancy Category X

Question 5

What FDA pregnancy category is this?

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Answer 5

Pregnancy Category D

Question 6

Pregnancy and Lactation Labeling Rule (PLLR or final rule) came out when?

Answer 6

December 2014

Question 7

when did the PLLR Changes go into effect?

Answer 7

on June 30, 2015