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Information Strategy

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Homework: UNIT 4 (Clinical Trials and Drug Development)

The Food and Drug Administration was created by Congress in 1906. What two subsequent Acts or Amendments are responsible for the rigorous drug development policy that is in place today?
Kefauver-Harris Drug Administration of 1962 and required that firms prove a drug's effectiveness before being marketed. Firms were also required to send adverse effects to the FDA.
Durham-Humprey Amendment changed how drugs were labeled This amendment required that drugs be labeled, “for sale by prescription only”. This new labeling requirement deemed prescription drugs as unsafe for self medication and needed physician supervision.

I’m a manufacturer planning to submit an application for approval of a new breast cancer vaccine. To which FDA center would this be submitted?
New Drug Application (NDA).

Please write a short description of each of the four phases of U.S. drug development. Sometimes, there is an additional phase. What is it, and where does it fall in the continuum?

Phase 1: Uses healthy volunteers (a few dozen up to 300) to conduct tests on the side effects, how the drug is metabolized, and excreted. If unacceptable toxicity is not revealed than they move on to the next phase.
Phase 2: There is emphasis on the effectiveness of a drug within people with certain conditions or diseases. Then the sponsors and the FDA determine how the study will be done.
Phase 3: This is when more information about safety is found. At this point the study is expanded to various dosage, various drug interactions (combination), and also various groups of people. The number of participants can range from several hundred to around 3,000. The additional phase is called postmarket requirement and commitment studies. This happens when the the sponsor agrees to after the FDA has approved the drug for marketing. This stage…...

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