Tag Archive: CMC

May 02

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 control” in a clinical trial to validate the clinical trial design or as an opportunity …

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Nov 02

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 …

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Jun 23

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 RTF letters, researchers at Leerink Swann found that 15 RTF letters were issued from 1998 …

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Nov 02

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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Oct 26

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 – size compatibility between CRO and sponsor, the cost, and the experience level of the CRO …

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Sep 27

Annual Reports: A Time for Reflection

You do something annual every year, don’t you? – George Noory Is it time stop and think over the events previous year?  Quite possibly.  In the rush to keep things moving, it’s all too easy to not take the time to pause and get a healthy dose of perspective.  Enter annual reports for drug/biologic development …

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Aug 27

Five Keys to Successful Adaptive Trials

Running adaptive trials is not easy. However, in a world of skyrocketing drug development costs, these trials are set to become essential tools in any drugmaker’s repertoire, especially early in clinical development. A poorly done adaptive trial can not only result in trial failure (i.e. failure of the study to produce useful information about the …

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Jun 18

DIA 2010 – Week in Review

The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location.  In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas of the Agency. As previously mentioned, Will Lee and I attended the meeting.  For those …

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Jun 02

Guidance for the Therapeutic Discovery Tax Credit

Credit you give yourself is not worth having. – Irving Thalberg For all you virtual biotechs and small start-up biotechs that survived the “Great Recession,” here is something to look forward to.  I’ve mentioned the Therapeutic Discovery Tax Credit before, but only in passing.  Now, though, the FDA Law Blog has brought to my attention …

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May 11

Switching from Paper to eCTD Submissions

Despite the many advantages of eCTD submissions, many smaller companies may still be reluctant to take the leap.  Concerns over the costs of implementing an eCTD publishing system and the lack of in-house expertise are often the primary stumbling blocks.  However, these concerns shouldn’t prevent you from moving forward.  An experienced partner with a proven …

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