Fifteen years ago the FDA set out to control cGMP labeling (Current Good Manufacturing Practice). The FDA first began its efforts to fix cGMP labeling in 1993 and eventually proposed a rule in 1997. The goal of its current final rule is to narrow the scope of its revisions made to cGMPs for cut and gang-printed labeling. It is believed that these two forms of labeling led to several drug recalls in the early 1990s. Another addition to the rule is to add a fourth control procedure which allows manufacturers to use any automated technique that physically prevents incorrect labeling. To read more about the FDA’s rule to control mislabeling, click here. To read more about this article, click here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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