drug development Flashcards
1
Q
pure food and drug act
A
problem of addiction to opium and cocaine
requires labeling and name ingredients
patent medications
2
Q
modified food, drug and cosmetic act
A
requires safety- caused by diethyleneglycol tragedy
drugs must be safe
3
Q
durham humphrey amendment
A
many new drugs- need to be regulated
RX vs OTC
4
Q
kefauver- harris amendment
A
phocomelia caused by thalidomide
required testing for safety and efficacy
5
Q
dietary supplement health and education
A
little regulation
regulates herbal products like food
not intended to diagnose, treat, cure, prevent any disease
