Monday, January 31, 2011

FDA CBER Office of Cellular, Tissue and Gene Therapies (OCTGT) Online Courses

Here is where the utility of the internet begins to shine and FDA is taking advantage of what it has to offer.

The following multimedia courses are currently offered online from CBER's Office of Cellual, Tissue and Gene Therapies (OCTGT). You may submit suggestions for future courses to
Course List

Sunday, January 30, 2011

US FDA CDRH 2011 Strategic Priorities

Recently FDA published its 2011 Strategic Poriorities document for CDRH.  A PDF version of the document is at

Among the identified goas was one set for January 31, 2011 (tomorrow).  FDA indicated its goal was:

  • By January 31, 2011, finalize a framework for validation and review of array CGH applications.

  • A Public Meeting was held on June 30, 2010 and a public docket was established which can be viewed at!searchResults;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2010-N-0259

    It will be interesting to see if tomorrow brings the announcement of the promised framework for validation and review of these tests.  I'm sure it will be virewed with great interest by the medical device industry as well as the the laboratory and academic communities.  It will surely give our first glimpse  into the direction FDA will take concerning the regulatory of laboratory developed tests (LDTs).  Will FDA meeting its stated goal?

    Saturday, January 29, 2011

    Friday, January 28, 2011

    The RAinfoBlog begins

    Today I start this blog as a place to share information of interest to regulatory affairs professionals.  I'm not sure where it will go, but initially I will post information that I hear about, items that I become aware of, and items that I find on the internet during my daily travels there.  Hopefully these may be of interest to some of you.  If I post something, it will at least have been interesting to me in some way.  The only criteria I have at this point is that an item relates to the US or xUS regulation of a product in one or more of the following areas:

       pharmaceutical products (Rx and OTC)
       biological products
       medical devices
       in vitro diagnositc products
       clinical laboratory testing
       personalized medicine
       companion diagnostics
       combination products
       genetic testing (including direct to consumer)
       recomibinant materials
       tobacco products
       holistic medicine

    As a regulatory professional myself (I have been doing this in the US since 1976), I find the area interesting, at times challenging, even sometimes a little bit absurd where all I can do is shake my head and carry on.  It is never dull. 

    There is a plethora of information readily available on the internet with more added each day, new laws, new regulatons, confusing and conflicting requirements, guidance and advice that do not specify expectations that can be relied upon to not change next month. 

    To try to make sense of this area and capture it in some way, in 1996 I started several activities to try to spread the gospel concerning available electronic information.  In those early days, it was dial up electronic telephone bulletin boards (I ran one) and "fax back" systems including some early efforts by the US Food and Drug administration with these tools, which now seem quaint and somewhat primitive.  It has now developed from simple internet websites (the remnants of mine is at  I hope to revive it and give it new life soon.  Websites have grown more sophisticated as time went by and many nice and useful "web portals" still exist.  (How many regulatory professionals do you know that still have a subscription the US Federal Register paper edition?  Mine whent by the wayside a long time ago.)  Now we are in the area of social media with RSS, Facebook, Twitter, Flickr, and blogs galore.  (Apologies to you all for any of the many social media tools I left out.) 

    I will leave the option turned on for you to post comments to this blog.  I hope you will do so in the spirit of sharing things you too find or have found useful.

    So here goes.  I'm sure it will be an INTERESTING EXPERIENCE.  I hope you find it so as well.

    Don Kafader
    Cary, North Carolina, United States