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FDA Delays Publication of Generic CBE Rule Until Fall 2015

By Charles Jaap, MBA, RAC 

US Food and Drug Administration (FDA) have delayed publication of a rule proposed last year that would allow generic drug sponsors to update safety warnings using the CBE process.

While the comment period was extended, there was no corresponding extension in the scheduled publication date of December 2014. FDA received more than 100 comments concerning the measure.

When announcing the extension, the FDA spokeswoman said: "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."

Pharmaceutical Development Group (PDG) will continue to update readers as events unfold.

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Pharmaceutical Development Group (PDG) is a drug and medical device consultant that continuously engages in meetings and interactions with the US Food and Drug Administration...
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