NDA vs. ANDA Review Process
Labeling
FDA wants physicians and other healthcare professionals to know that they can get the same information on both the brand and generic label of a drug, and that the chemical listed is going to behave the same in both. The only real difference is how it is supplied in terms of color or shape.
In certain cases, FDA may delete portions of the labeling protected by patent or exclusivity. For example, if the company adds a new indication or strength, that information will be deleted.
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