More Time Needed for Comments on Continuous Manufacturing Draft Guidance  

The pre-publication page of the Federal Register Notice posted today (here) a reopening of the comment period for the draft guidance Quality Considerations for Continuous Manufacturing which was originally released February 27, 2019.  That guidance can be found here  .

While some (but not too many) firms have embraced the concept of continuous manufacturing, others are either reluctant or just set against the concept.  Arguments are that it is too expensive, or it is just not right for the specific firm.  Many generic companies don’t see the value of the expense or feel that because of the number of products in their portfolio, it is just not practical.

While it is not uncommon for the FDA to reopen a comment period, it is clear that firms have a lot to say about the issue and need more time to solidify their views.  At the time of publication of this blog post, there have been 21 comments to the draft guidance submitted to the docket (here) but, from a quick review, it appears that only one has come from a generic manufacturer.  This, in and of itself, may be telling.