When Will the FDA Approve a Drug for General Use

When will the FDA approve a drug for general use even if it can cause birth defects?

A) If the risk to the fetus is so small in number that it is unlikely to occur
B) If the benefits of the drug are far greater than the risk to the fetus
C) If the manufacturer can demonstrate that the adverse effects no longer exist in certain breeds
D) If the therapeutic index has narrowed to such a number that the FDA is now comfortable with the risk