The Kefauver Amendments of 1962 to the Food Drug and Cosmetic Act added requirements except: a. All...

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Chemistry

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

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The Food and Drug Administration FDA is a regulatory agency within the Department of Health and Human Services A key responsibility is to regulate the safety and effectiveness of drugs sold in the United States FDA divides that responsibility into two phases preapproval premarket and postapproval postmarket FDA reviews manufacturers applications to market drugs in the United States a drug may not be sold unless it has FDA approval The agency continues its oversight of drug safety and effectiveness as long as the drug is on the market Beginning with the Food and Drugs Act of 1906 Congress has incrementally refined and expanded FDAs See Answer

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