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the approval of a new drug application by the fda allows for which of the following
1.Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks? 2. Is the drug’s proposed labeling (package insert) appropriate, and what should it contain? and 3. [ Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the
drug’s identity, strength, quality, and purity? source wikipedia.org ]
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Original conversation
User: the approval of a new drug application by the fda allows for which of the following

Weegy: 1.Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks? 2. Is the drug’s proposed labeling (package insert) appropriate, and what should it contain? and 3. [ Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity? source wikipedia.org ]
Expert answered|sharpies|Points 1918|

User: The approval of a new drug application (NDA) by the FDA allows for which of the following? A. The manufacturer is allowed to sell the drug in the United States. B. The drug is allowed to be tested in animals for safety. C. The drug is allowed to be tested in humans for the first time. D. The drug is allowed to be shipped for the first time through interstate commerce

Weegy: The answer is C. The drug is allowed to be tested in humans for the first time.
Expert answered|sharpies|Points 1918|

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Asked 6/15/2011 7:11:29 PM
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