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Omnitrope Clears FDA: Is the Next Hurdle Congress?

This article was originally published in RPM Report

Executive Summary

The debate over an abbreviated biologics pathway took a big step forward with the Food & Drug Administration's approval of Sandoz' recombinant human growth hormone Omnitrope. The approval itself is precedent setting, but the bigger ramifications are political: the action steps up the pressure on Congress to address the issue head-on.

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