BJ Stupak was a popular seventeen years old that did not show any sign of depression, according to his parents Bart and Laurie Stupak. On the other hand his friends heard BJ talking about how his grades were not up to s

Under current law, all new drugs need proof that they work effectively and are safe. There is always some risk of an adverse reaction, but when the benefits are higher than the risks, it is considered safe enough to approve. FDA requirements include that a sponsor must submit data showing that the drug is reasonably safe for use. First they compile existing non-clinical data from laboratory or animal studies. Second they gather the data from previous testing in the United States. Next they go through new pre-clinical studies to provide proof to support the safety of administering the drug to humans. FDA requires safety updates four months after it is submitted. The decision of the FDA's approval comes down to two questions. Do the results provide evidence of effectiveness? Does the results show the drug is safe under the conditions of use in the proposed label?

Due to the concern about the drugs risks, FDA continues to evaluate Accutane and work with the manufacturer to maximize safe use of

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Approximate Word count = 673
Approximate Pages = 3 (250 words per page double spaced)