Tag Archives: CMC

Regulatory Chemistry, Manufacturing and Controls Requirements for using Comparator Drug Products in Clinical Trials

Randal R. Lane M.B.A., RAC; Vice President Pharmaceutical Development; Cato Research An integral part of the drug development process is the use of marketed products as comparator products in clinical trials. These comparator products are used either as a “positive … Continue reading

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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 … Continue reading

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Is FDA Issuing More Refuse-to-File Letters?

  The June 2011 issue of Nature Reviews: Drug Discovery (volume 10, page 403) includes an interesting news brief regarding the apparent increase in Refuse-to-File (RTF) letters being issued by FDA in recent years. In a review of publicly available … Continue reading

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October 2010 FDA Guidances

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 October 2010 (links go directly to PDF documents).

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Vendor Selection – All that Glitters is Not Gold

One of the most important, and difficult, decisions a company has to make is selecting the right contract research organization (CRO) for outsourcing its nonclinical, manufacturing, clinical and regulatory activities.  Several variables determine what makes a good outsourcing partner – … Continue reading

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