FDA Delays Publication of Generic Drug CBE Rule Until Fall 2015

Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)

In a move that was not entirely unexpected, FDA delayed publication of a rule proposed last year that would allow generic drug sponsors to update safety warnings using the changes being effected (CBE) process. While the comment period had earlier been extended, there was no corresponding extension in the scheduled publication date of December 2014. In the meantime, FDA received well over 100 comments about the measure. In announcing the extension, the FDA spokeswoman noted that “FDA received a great deal of public input from various stakeholders during the comment period on the proposed rule. We are committed to reviewing and considering all of the comments received as we develop the final rule”. PDG will continue to keep our readers posted as events unfold.

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