What’s up at FDA?

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? By my count DSI went from no Warning Letters issued in fiscal years 2005 and 06 to 12 or so issued in FY-2008. That’s quite an increase and it has certainly caught my attention. How about you?

In addition, I am quite curious who will be appointed the next FDA Commissioner. The lack of leadership at FDA has been hurting us all.

Finally, I wanted to share the results of a continuing conversation that I have had with colleagues and the GCP Questions at FDA regarding the preservation of e-mails for clinical trials. Here is an edited down version of the discussion:

E6 8.3.11, intends that e-mails documenting any “agreements or significant discussions…” about the study be preserved. Suggestions of keeping a protocol-specific e-mail folder and/or burning a CD at the end of the study, converting e-mails into a PDF format, or adopting a procedure to make certified copies of the e-mails, are all acceptable methods to achieve this. (FDA does not have any regulatory requirements as to the type of CD or DVD that might be used to preserve information (presumably to meet the regulatory requirements concerning clinical data/records). A company just needs to make certain that whatever media it uses does so in a manner that preserves the integrity of the original data/information.)

Please let me know what you think about it all.

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Visit the TMF Page at the Top Right of the Blog! I am trying to assemble resources for those of us concerned with the Trial Master File. I welcome any contributions you might have of interesting articles and resource documents.

2 Responses to What’s up at FDA?

  1. tjkuhn says:

    Welcome to the Blogosphere Carl. I’ve added a link to you on my site. For those who don’t know Carl. He’s a great resource and a font of industry (and Agency) information. I’m looking forward to seeing what he shares here.

    All the Best,


  2. Carl's Blog on FDA Stuff says:

    Thanks Tim,

    I met Tim last year at SQA and enjoyed his comments at a GCP workshop. I hope folks take time to read your blog as well. Interesting stuff. It is listed on my Blogroll.



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