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August 2010 FDA Guidances

EvanRichardson — Tue, 07 Sep 2010 14:50:25 +0000

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 August 2010 (links go directly to PDF documents). Special … Continue reading →

Five Keys to Successful Adaptive Trials

EvanRichardson — Fri, 27 Aug 2010 14:00:47 +0000

This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research. Running adaptive trials is not easy. However, in a world of skyrocketing drug development costs, these trials are … Continue reading →

CDRH Proposes Changes to the 510(k) Pathway

LeoDiNapoli — Mon, 23 Aug 2010 14:00:59 +0000

All for one, one for all, that is our device. – Alexandre Dumas The Center for Devices and Radiological Health (CDRH) has been somewhat under fire in recent years, so it surprised no one when it undertook a long look … Continue reading →

Important Steps Forward for Early Detection and Diagnose of Alzheimer’s Disease

EvanRichardson — Fri, 20 Aug 2010 18:57:04 +0000

Image via Wikipedia This is a guest post by Erik Berglund, M.D., Ph.D. Erik is a Senior Regulatory Scientist and the Associate Managing Director of Cato Research‘s San Francisco, CA office. In a recent report by Geert De Meyer of … Continue reading →

Joint Statistical Meetings 2010 Retrospective: A CRO Statistician’s Perspective

EvanRichardson — Mon, 16 Aug 2010 14:44:44 +0000

Image via Wikipedia This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research. The Joint Statistical Meetings is often a good place to learn about emerging issues in the … Continue reading →

Accelerated Approval

LeoDiNapoli — Wed, 11 Aug 2010 14:00:58 +0000

Image via Wikipedia One must strike the right balance between speed and quality. – Clare Short Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics: … Continue reading →

Bookmarks – Collapsed or Expanded?

EvanRichardson — Tue, 10 Aug 2010 14:00:41 +0000

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 →

July 2010 FDA Guidances

EvanRichardson — Mon, 09 Aug 2010 17:25:51 +0000

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 →

Medical Imaging in Clinical Trials

EvanRichardson — Fri, 06 Aug 2010 14:00:26 +0000

Image via Wikipedia This is a guest post by Catherine Sheppard, Ph.D. Catherine is a Senior Clinical Scientist in Cato Research’s Montreal, Canada office. The evolution of medical imaging has greatly improved the rate and accuracy of diagnosis of disease … Continue reading →

GlobalSubmit Suite 2010 Beta Test – Part 1

EvanRichardson — Wed, 04 Aug 2010 14:00:08 +0000

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 →