Thank you FDA for finally getting rid of one of the most confusing terms in regulatory language - The Approvable Letter! Many a project team meeting have I had to over enunciate APPROVAL vs. APPROVABLE to the hoards of waiting listeners when the FDA Action period came to a close. Now, as announced by FDA yesterday and found here on their web site http://www.fda.gov/bbs/topics/NEWS/2008/NEW01859.html we have a much more focused approach to the conclusion (maybe) of the review process - The Complete Response! I love it!! They review it, here is what they think is missing, let’s keep moving . . . speaking of moving, it would appear I am on a blog roll . . .

As a follow-up to my last blog about the DIA Annual Meeting, I did want to share a new acronym that I learned. It isn’t really new I guess, but I hadn’t heard or seen it as much as I did that last week in June.

REMS: Risk Evaluation and Mitigation Strategy. It is a part of FDAAA, which of course relates back to PDUFA IV. I am having a bit of a problem distinguishing it from Risk Management Plans, especially after reading this in the Federal Register [Docket No. FDA-20084-0174]:

Section 909(b)(3) of FDAAA states: “No later than 180 days after the effective date of this Act, the holder of an approved application for which a risk evaluation and mitigation strategy is deemed to be in effect *** shall submit to the Secretary a proposed risk evaluation and mitigation strategy. Such proposed strategy is subject to section 505-1 of the Acts as if included in such application at the time of the submission of the applications to the Secretary.”

So, let me get this straight, if you have a REMS in effect, you need to submit a proposed REMS . . . they are due 21 Sep 08 and guidance for writing them is due out shortly. I don’t suppose they will resemble the RiskMaps companies have to write for the EU . . .

All for now . . next topic: RPS2!