Regulatory Matters

Octagon's Blogs and Forums

admin — Thu, 10 Jun 2010 13:26:00 -0400

BLOGS

eCTD / RPS Discussion Forum

Cleaning House

admin — Mon, 24 May 2010 15:28:55 -0400

Spring came early to Pennsylvania this year in one of those it is 40 degrees on Tuesday and 80 on Wednesday temperature shifts. This usually elicits the typical responses from people depending on your age. For the younger generations this usually means the start of flip flop season, which in case you hadn't figured out does not include me. I wear flip flops in public showers and at the beach. For me, it is more about cleaning - both at home and at work. I won't bore you with my domestic activities but I do have something interesting to share that is work related.

Regulatory Matters

Shakeup at the Top

kbouldin — Mon, 06 Apr 2009 13:52:55 -0400

In deciding what to have as my next blog topic I was torn between the mega-merger news within the Pharma industry or the appointments at the top of the HHS/FDA hierarchy. I couldn’t decide between the two so I am blogging on both.

Regulatory Matters

My Whirlwind 4th Quarter

admin — Mon, 19 Jan 2009 22:19:20 -0500

I always seem to start off my blogs the way I do my annual Holiday letter, with an apology…sorry I haven’t written or called or had any normal human communication with you, my family and friends. Then I go on to explain why normal human communication has escaped me. Since I don’t really see “blogging” as normal human communication (again showing my age), I will dispense with the apologies and go on to tell you about what I learned during my incredibly hectic 4th Quarter of 2008. These are the real reasons I had no normal human communication during that time.

Regulatory Matters

So Long Approvable Letters!

admin — Sun, 03 Aug 2008 23:20:46 -0400

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!!

Regulatory Matters

DIA Annual Update

admin — Thu, 10 Jul 2008 23:21:59 -0400

Wow! I am just now recovering from a week in Boston at the 44th Annual DIA Meeting.

It was a great meeting with a record number of attendees (8700+), sessions, and exhibitors. I was fortunate enough to have been on the Program Committee for this meeting as I will be next year and in 2010. It is a 3 year commitment and has been an eye opening experience.

Let me share with you all some thoughts about the meeting, beginning with the Keynote.

Regulatory Matters

Benefits/Risks and How it is Ascertained

admin — Sun, 02 Dec 2007 22:24:15 -0500

Apologies for the delay in blogging . . . we recently had a death in our family. Actually, it was my Father-in-law, who lived to be 81 despite suffering from heart failure, high blood pressure and COPD. If you take away the last 6 months, he actually was a modern medical miracle. I would like his case study and that of my own father, who is also 81, to be the subject of this blog. Not personal stuff, although both of them are truly great men, who represent the “greatest generation” in more ways than one.

Regulatory Matters

How to Act at FDA Meetings

admin — Thu, 09 Aug 2007 23:25:14 -0400

So the reaction to my first blog just among my friends and coworkers was pretty good, although rather limited…they liked my Regulatory Affairs and Wine connection and would like me to follow it up with Regulatory Affairs and Coffee and associated with that Regulatory Affairs and Chocolate…what can I say, we spend a lot of time thinking about what we put in our mouths! The subject of this blog, however, is more to do with what comes out of our mouths…or “How to Act at FDA Meetings” when somebody is actually listening and writing down what you say!

Regulatory Matters

My First Blog

nsmerkanich — Wed, 18 Jul 2007 01:12:59 -0400

So, suffice it to say, I am approaching 50 years old and thus have never blogged before, but the idea was planted last year at an industry award dinner when I was seated at a table with the award winning blogger, who blogged about fashion, and was about my age. So, I figured (as I have with everything from regulatory submissions to parenting), if she can do it so can I!

Here goes . . . who am I?

Regulatory Matters