This blog started on 16 February 2009 as “Carl’s Blog on FDA Stuff.” At the time I said:
“This blog will attempt to discuss some of the changes that are taking place at FDA and (hopefully) helpful interpretations of regulations and guidance documents. Future posts will include an analysis of Bioresearch Monitoring Warning Letters. For example, have people been noticing the large increase in Warning Letters issued by CDER/Division of Scientific Investigations in the past two years or so?”
Time marches on and the focus of the blog has moved towards trying to craft some meaningful perspectives for GxP professionals and members of the public who are interested in commentary on the life science industry, clinical trials, and (of course) FDA.
GxP Perspectives: I’m going to make a few more changes to the blog in the next few weeks and soon will be including guest commentaries by GxP professionals on different aspects of our business. What I don’t know could fill a book (maybe two) and I want to hear from others on the practical issues that we face, such as electronic medical records, GLP issues, pharmacovigilance, interpreting guidance documents, and just what belongs in a trial master file. If you are interested in submitting a guest commentary, just add a comment indicating your interest and I will get back to you. (WordPress provides me with the email of anyone who comments which is not made public.) I am interested in hearing what you have to say.
I’ve also started inserting some photos and graphics, we don’t want the Blog to be too boring.
Blogroll: For those of you interested in the financial aspects of our industry – and others – Check out Hedge Hodge at: