Tag Archive: GLP

Sep 19 2013

New FDA Guidances for August 2013

New guidances out last month include several device related guidances including a beloved (at least by me) Q&A guidance on GLPs in premarket device submissions; a listing of FY 2014 medical device small business user fees; and new information on risk-based monitoring, which is being pushed both by FDA and industry. Select Updates for Non-Clinical …

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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 …

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Jun 02 2010

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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