Tag Archive: ICH

Feb 08 2013

The Changing Landscape of Postmarketing Safety Reporting

Drugs are approved for marketing on the basis of clinical trials that are, generally speaking, carried out on relatively small numbers of people.  The goal of these trials are to identify the risks inherent in taking a drug while also assessing the drug’s efficacy in the treatment of the intended indication.  However, once a drug …

Continue reading »

Nov 02 2011

Project Management for Biotech Companies

In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success.  Large organizations understand the value that project management can contribute to a successful project.  The smaller companies tend to lag behind and often do not recognize that project management is not too complex or …

Continue reading »

May 03 2011

India: The next up and coming location to run clinical trials?

  Until recent years, clinical trials have been conducted primarily in the US and in Europe, due to higher health standards and overall standard of care for patients.  However, more and more pharmaceutical companies and contract research organizations (CROs) are being pressured to reduce timelines and costs.  Up until about a decade ago, India was …

Continue reading »

Aug 10 2010

Bookmarks – Collapsed or Expanded?

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 if there is a specific reason that we do this, since the FDA eCTD guidances …

Continue reading »

Aug 09 2010

July 2010 FDA Guidances

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 Interest Guidances/Information Date Posted Residual Drug in Transdermal and Related Drug Delivery Systems (Draft) 8/02/2010 …

Continue reading »