Question

(Health Affairs) The reason why reciprocity can be an issue for the FDA is that if it would automatically approve drugs already tested and approved by the EMA,

it might be less effective here as americans have a different biological structure than europeans.

it might be deadly and lethal here as americans have a different biological structure than europeans.

then the FDA will be deprived of huge application review fees that will not be paid if they automatically approve these drugs since the subject U.S. drug manufacturers will not have to go through a testing process here.

a and c

b and c

Answer 1

The reason why reciprocity can be an issue for the FDA is that if it would automatically approve drugs already tested and approved by the EMA,is that then the FDA will be deprived of huge application review fees that will not be paid if they automatically approve these drugs since the subject U.S. drug manufacturers will not have to go through a testing process here. So the correct option is C.