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What new requirements for drug manufacturers were mandated by Kefauver Harris Drug Amendaments, compared to 1938...

What new requirements for drug manufacturers were mandated by Kefauver Harris Drug Amendaments, compared to 1938 Food, Drug and cosmetic Act? Why is it important for public health?
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  • manufacturers should also prove the effectiveness of the drug before releasing into the market along with the safety
  • manufacturers were required to test the effectiveness in clinical trials with consent of informed individuals
  • the ammedaments made FDA approval necessary with 180 days in its hands to act on a drug application
  • it became mandatory for FDA to test the effectiveness of the drugs also releaseed between 1938 and 1962
  • FDA became in control for advertising the drug properyl with complete information including the side effects
  • Controlled the market price of the generic drugs so that the same medication should not be sold under new names as expensive meds,

This was necessary to protect the public from harmful medication this was brought in action after the use of Thalidomide for morning sickness in pregnant women were causing birth defects.

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