The Kefauver Amendments of 1962 to the Food Drug and CosmeticAct added requirements except:
a. All drugs must be safe and effective, including all drugsapproved by FDA since 1938
b. Drug manufacturers must collect safety information once aproduct is approved
c. New drug approvals were for a five year period and had to berenewed every five years to remain on the market
d. New drugs require FDA consent when they are studied beforeapproval during what would be known as the IND phases
