The FDA's pregnancy safety designation of Category A for a drug means:
A) no adequate animal studies or adequate studies of pregnant women have been done.
B) animal studies have demonstrated adverse effects, but there are no adequate studies in pregnant women; benefits may be acceptable despite the potential risks.
C) adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester or later trimesters.
D) fetal risk has been demonstrated, which outweighs any possible benefit to the mother; avoid using in pregnant or potentially pregnant patients.
Question 2
A patient informs you that he has had his gallbladder surgically removed. Based on the physiology of the gallbladder, which one of the following is true?
A) He may have difficulty digesting large amounts of fats.
B) He cannot store glycogen produced by the liver.
C) He will be more prone to gastric ulcers.
D) He must avoid meals high in complex carbohydrates.
A normal pregnancy.
Animal Cell
Buccal drug administration
Vaginal drug administration: (b) using an applicator to instill a vaginal cream
FDA Pregnancy Classifications
A new drug development time line with the four phases of drug approval.