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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