Monthly Archives: August 2010

Bookmarks – Collapsed or Expanded?

Posted on 10 August 2010 by Evan Richardson

At Cato Research, part of our standard document preparation work for eCTD submission documents is to save every PDF file with the bookmarks collapsed (i.e. only the top level bookmark is visible when the document is opened).  We’re often asked … Continue reading →

Posted in eCTD, FDA | Tagged , , , , , , | 5 Comments

July 2010 FDA Guidances

Posted on 9 August 2010 by Ask-Cato.com Contributor

Image via Wikipedia Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in July 2010 (links go directly to PDF documents). Special … Continue reading →

Posted in FDA, Regulatory Strategy | Tagged , , , , , , , | 1 Comment

Medical Imaging in Clinical Trials

Posted on 6 August 2010 by Ask-Cato.com Contributor

Image via Wikipedia The evolution of medical imaging has greatly improved the rate and accuracy of diagnosis of disease in patients, this in turn has led to more timely treatment, and ultimately better prognosis for patients.  Imaging during clinical trials … Continue reading →

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GlobalSubmit Suite 2010 Beta Test

Posted on 4 August 2010 by Evan Richardson

GlobalSubmit is hard at work on the next version of their software suite.  In addition to several improvements to both REVIEW™ and VALIDATE™, the next update will also include PUBLISH™, their long anticipated eCTD and RPS publishing tool.  As I’ve … Continue reading →

Posted in eCTD, Industry News | Tagged , , , , , , , | 2 Comments

Safety Data and Transparency

Posted on 2 August 2010 by Leo DiNapoli

For the safety of all the public, for the safety of our officers, we need to understand intimately all that can be learned – William Bratton You may have noticed that transparency has been a topic of interest lately (for … Continue reading →

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