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Monthly Archives: July 2010
Give Your Scientists an Edge – Partner with a CRO!
Image via Wikipedia In the fast paced R&D world, every biotech is looking for an edge to keep them ahead of their competitors and to help them achieve their goal of either getting a drug to human clinical trials or … Continue reading
Posted in Regulatory Strategy, Venture Capital
Tagged biotech, clinical trials, drug development, nonclinical research, outsourcing, venture capital
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June 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 June 2010 (links go directly to PDF documents). Special … Continue reading
Posted in FDA
Tagged bioequivalence, FDA, guest post, guidance, in vitro diagnostics, medical devices
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Check Out Our New Blog Design
Image via Wikipedia If you’re reading this, then you’re also seeing our new blog design. We’ve replaced the previous WordPress theme (Pearl, available here) with a customized version of the Twenty Ten 1.0 theme that was recently released with WordPress … Continue reading
OIG Report Shows Increasing Use of Foreign Clinical Trials in Marketing Applications (and Challenges for the FDA)
There are no foreign lands. It is the traveler only who is foreign. – Robert Louis Stevenson Global. That’s one of the buzz words/ideas that has gripped modern drug development. In particular, there is a notion that foreign countries represent … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged biologics, BLA, clinical trials, drug development, FDA, GCP, IND, inspections, marketing application, NDA
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505(b)(2) Marketing Applications – Bridging the Gaps
There is no doubt that the drug development business is very expensive and development can take many years before a viable, money-generating product can be marketed. A strategy some of our clients implement to more quickly and more inexpensively develop … Continue reading
Posted in FDA, Regulatory Strategy
Tagged 505(b)(2), bioequivalence, drug development, efficacy, FDA, novel therapeutic, pivotal studies, route of administration, safety
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