Law360 recently quoted Husch Blackwell attorney Don Mizerk in an article about the FDA’s new request for comments. In the announcement, the FDA established a public docket to receive suggestions for ways to improve the quality of abbreviated new drug applications (ANDAs) and for the FDA to learn about difficulties sponsors are having with ANDA submissions. The FDA indicated it is willing to provide additional guidance to the industry in order to improve the completeness and quality of submissions.
Law360’s article discussed five takeaways from the announcement. (Article is accessed by subscription only.)
FDA listed a number of purported recurring problems in ANDA submissions as the premise for the announcement. According to Don Mizerk, as he was quoted in the article, “[t]hese problems that they have identified here are really not very serious” and are “not an excuse for the delays we’ve seen in the processing of applications.”
While it remains to be seen whether FDA will make sweeping changes based on the comments it receives in response to this announcement, it is likely that this announcement is part of FDA’s effort to manage industry expectations in light of the Generic Drug User Fee Amendments of 2012 (GDUFA). GDUFA imposes requirements on FDA to improve the processing of human generic drug applications.
Comments are due to the FDA by March 24, 2014.