Monthly Archives: March 2010

Document Authoring Best Practices for eCTD Submissions Webinar

Posted on 16 March 2010 by Evan Richardson

Cato Research and GlobalSubmit are hosting a free webinar on Thursday, 25 March 2010 from 2-3 PM EDT, entitled “Document Authoring Best Practices for eCTD Submissions.” This presentation will provide an overview of the advantages and challenges related to authoring documents … Continue reading →

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Choosing a Proprietary Name

Posted on 16 March 2010 by Ask-Cato.com Contributor

What’s in a name? – Juliet in Shakespeare’s Romeo and Juliet (II, ii, 1-2) Specifically, what’s in a Trade Name of a drug? Answer – Medication errors. For instance, Takeda Pharmaceuticals will change the name of a heartburn drug KapidexTM … Continue reading →

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Cato at the SQA 26th Annual Meeting and Quality College

Posted on 12 March 2010 by Evan Richardson

The Society of Quality Assurance (SQA) will be holding its 26th Annual Meeting and Quality College on 25-30 April 2010 in Cincinnati, OH.  Three days of plenary and concurrent sessions will explore hot topics and the latest regulatory interpretations in … Continue reading →

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FDA Realigns Divisions and Current Applications

Posted on 11 March 2010 by Leo DiNapoli

Effective 15 March 2010, the FDA will be realigning several key review divisions within the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND).  Importantly, this means that the review responsibility for many applications (eg, INDs, NDAs, … Continue reading →

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Special Protocol Assessments – FDA Transparency vs. Corporate Responsibility

Posted on 10 March 2010 by Leo DiNapoli

One man’s transparency is another’s humiliation. – Gerry Adams Before I get started, let me be clear:  Transparency is a good thing. After FDA Commissioner Margaret Hamburg took office on 18 May 2009, she wasted no time in pushing for … Continue reading →

Posted in FDA, Industry News | Tagged , , , | 1 Comment