X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 85 / 263

657 views

0 shares

0 downloads

0 comments

85 / 263

1

without getting into the multiplicity of times that the test is done over the course of a year for the companies.

So now that I've seen the new work particularly, I think I could even go a little further in a personal opinion and say that somebody who wants to argue for zero tolerance criterion really has the burden of proof on them at this point.

So as you did here, the IPAC proposal does drop it, and the last point was really made for me prior to this morning.  I think the zero tolerance criterion certainly does seem to engender a level of comfort and I don't know whether or not that comfort will still be there or whether there's enough data at this point to make people comfortable about dropping it.  Clearly, as I'm saying, in my opinion, that's really the way to be going.

So summarizing the different issues, so yes, I'm saying I agree that the IPAC proposal does address the issues that have been raised about the FDA draft guidance.

Now, one of the major claims in the IPAC-RS proposal is at the same time as you can maintain the level of consumer risk or even improve the level of consumer risk compared to the FDA criterion, you can still reduce

Document info
Document views657
Page views657
Page last viewedThu Dec 08 16:34:55 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments