Leah_Kleylein's blog

FDA creates Guidance on ISS/ISE Placement

2009-04-21T10:34:38-04:00

This morning I saw that FDA put out an actual guidance on placement of the ISS/ISE.

Before they had the webpage (and still reference it in the guidance): http://www.fda.gov/cder/regulatory/ersr/ISS_ISE_clarification.htm

The guidance can be found at: http://www.fda.gov/cder/guidance/8524fnl.pdf

They've reproduced the same table from the webpage in the guidance (as Table 1) and then just spent time talking about it all.

They also describe the exception case:

C. Exceptions

There may be situations in which sections 2.7.3, Summary of Clinical Efficacy, and 2.7.4, Summary of Clinical Safety, would be sufficiently detailed to serve as the narrative portion of the ISE and ISS, respectively, while still concise enough to meet the suggested size limitations for Module 2. This situation is rare but can occur if the application is small and consists of a single study or a number of small studies. In our experience, the narrative portion of the ISE often is more amenable for inclusion in Module 2 than is the ISS. In such situations, the ISE and ISS can be split across Module 2 and Module 5, with the narrative portion located in section 2.7.3 or 2.7.4 and the appendices of tables, figures, and datasets located in section 5.3.5.3. If the ISE or ISS is split across modules in this way, it is critical to include a clear explanation of where the parts are located. This explanation should be placed both in Module 2 (section 2.7.3 or 2.7.4) and in Module 5 (section 5.3.5.3).

Finally, they give some examples of real life cases that have been taken from various FDA presentations to the industry.

Nothing major, but good to know this now exists.

Swissmedic to accept eCTD starting in 2010

2009-03-23T09:18:10-04:00

The Swiss Health Authority Swissmedic will accept applications in eCTD format starting in January 2010. They have an announcement for all this on their website, but it doesn't do you much good unless you read German, which sadly, I cannot.

http://www.swissmedic.ch/aktuell/00003/00870/index.html?lang=en

It's not that hard to figure out, but it's better not to to take chances. eCTDblog.com has kindly put it all through a google translator and voila, English! The sentence structure is still German though, and that's kind of cool.

http://www.ectdblog.com/2009/03/swissmedic-ectd-announcement.html

For those of you that don't care about all this language stuff and just want the information, here are the highlights:

January 2009 - Project Kickoff

March 2009 and on - Publication of Project information on Swissmedic webpage

July 2009 - First version of Swiss eCTD specification and guidance will be available

October 2009 - Final version of Swiss eCTD specification and guidance available

January 2010 - Applications in eCTD format that are of an acceptable submission type will be accepted

RPS Codes Posted on NCI Website

2009-03-20T07:42:08-04:00

A step in the right direction.....codes for RPS have been posted on the NCI website. It's not pretty yet, but it's there. However, right now, the codes provided are only the table of contents sections for ICH’s Common Technical Document (Modules 2-5) and the US FDA’s regional table of contents (Module 1).

Here is where an explanation is posted by Jason Rock:

http://theectdsummit.com/summit/?p=299

Here you can go straight to the codes:

http://nciterms.nci.nih.gov/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C79148&bookmarktag=1

FDA Inspections and the Dreaded 483

2009-02-25T11:27:16-05:00

There is a nice brief discussion of what a 483 is (in case you are dying to know) at the path below, along with a link to some suggestions that FDA has put out there on how to respond to one if you get one.

http://www.eyeonfda.com/eye_on_fda/2009/02/fda-presentation-on-responses-to-483s.html

Guidances CDER is Planning for 2009

2009-02-10T09:00:48-05:00

CDER has put out their list for 2009 of planned guidances. The few that relate directly (or indirectly) to Regulatory Operations are:

Providing Regulatory Submissions in Electronic Format – Analysis Datasets and Documentation
Submission of Summary Bioequivalence Data for ANDAs
IND Safety Reporting
Content and Format of the Clinical Pharmacology Section (Labeling)
Drug Names and Dosage Forms (Labeling)

The entire list can be found here: http://www.fda.gov/cder/guidance/CY09.pdf

Australian eCTD Guidance

2009-01-19T09:47:30-05:00

Australia has put out some updated guidance and draft guidance on eCTD. There is now a version 2.1 of the AU Module 1 Specification, and a draft version 1.5 of their guidance on submissions in eCTD format. Both can be found on the TGA's website, the link is below. Happy reading!

http://www.tga.gov.au/docs/html/eugctd.htm

Hungary and the eCTD

2009-01-05T09:19:33-05:00

Welcome back to work everyone!!! I hope that you all enjoy a happy and prosperous 2009, we certainly all deserve it I think after that mess of a last year. Anyway, back to work....

I found a link to a presentation on another blog that was by Dr. Gergely Zajzon of the Hungarian health authority on their status in using eCTDs. Hungary was an early adopter of eCTD and has been actively supporting it at various conferences for the past few years. The link below is to a presentation given last fall that lists some of the data around eCTDs received by Hungary, what they believe the positives are in reviewing eCTD and their work in digitizing the already received submissions.

http://www.topra.org/files/assets/sym2008/TOPRA_Gergely_Zajzon_eSubmissions_in_Hungary.pdf

December and RegOps

2008-12-17T07:39:37-05:00

This is my favorite time of year, I admit it. I love Christmas and the holidays, garlands and lights on everything, sugary snacks and liquor abounding.

But being in submission publishing always made it a little tough to fully enjoy the buildup because there are always those end of year submissions. They are in addition to the end of quarter, end of month, end of week, end of day submissions of course. But end of year was all of those rolled into one; so you can’t really relax until that last submission is out the door. THEN your holidays start.

One year I was working on an electronic IND that was to be submitted on December 18^th. The protocol (including list of references!) was not finalized until the day before. I remember just sitting at my desk, with my little Christmas tree, and Christmas music streaming on my computer, pounding away at finishing up that IND. I’m grateful for that streaming Christmas music, I know it’s a waste of bandwidth, but it cheered me and kept me going. Also cheering were the gifts of vodka from my CMC co-workers, who felt guilty for their lateness as well. Not that we had liquor at the workplace, of course. Because that would be wrong.

It’s been a couple years now that I haven’t actually been in the midst of end of year submissions – either on the periphery “managing”, or just not involved. And because of that, I get to take loads of vacation days at the end of the year. I can’t even begin to explain my guilt at this!! I can’t shake it though. I feel like I am some jerky person lolling around when I know, I KNOW somewhere someone is working on a submission for December 23^rd or 31^st and I should be helping them.

I even still have a hard time with end of day and end of week meetings. There’s nothing more annoying than getting some meeting scheduled when you have 3 submissions to go out that day and you’re told your presence is mandatory. So for years, I made sure that when I scheduled meetings that involved RegOps people, it was morning or early afternoon, and certainly not on a Friday. Of course, I don’t need to worry about this in my current position, and yet I still get annoyed at late day and end-of-week meetings. Okay, not annoyed, but you know what I mean, my first knee-jerk reaction is hey, I’m going to need that time….oh wait, no I don’t. I wonder if I’ll ever get past that, or if it’s so ingrained after decades, it’s not going anywhere.

I wonder if as we advance even more with the electronic publishing, will all this go away? Will the end-of-whatever rushes go away? Probably not, we’ll still have Reg Affairs folks who try to cram-in last minute submissions. You know who you are!

So, to all my former and current RegOps co-workers, my holiday wish for you is timely and accurate submissions. Whatever holidays you celebrate, I hope they are happy!!!