Category Archives: Uncategorized

FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies

Greg Hileman, Ph.D., Sr. Director and Principle Regulatory Scientist of Cato Research The International Conference on Harmonization (ICH) last updated its guidance “THE CLINICAL EVALUATION OF QT/QTC INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS (ICH E14 (R3)) in 2005. … Continue reading

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New FDA Guidances for December 2016

By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in December 2016 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. … Continue reading

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New FDA Guidances for September 2014

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in September, are posted. In addition, upcoming advisory committee meetings and other public meetings hosted by FDA are listed … Continue reading

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Effective Partnerships for Virtual Biotech Companies–how companies and partners can work efficiently together

Lisa R. Sanders, Ph.D., R.A.C., Sr. Clinical Scientist II at Cato Research No matter what you call it–outsourcing, contracting, partnering–for a virtual biotech, partnership is vital to success. Virtual companies face specific hurdles such as the lack of a central … Continue reading

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FDA’s Comprehensive Status Report on Personalized Medicine

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA published a report, prepared by the Office of the Commissioner in the Office of Medical Products and Tobacco, in October 2013 entitled “Paving the Way for Personalized Medicine: … Continue reading

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