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Category Archives: Regulatory Affairs
New FDA Guidances for August 2017
By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in August 2017 are posted. In … Continue reading
New FDA Guidances for July 2017
By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in July 2017 are posted. In … Continue reading
Posted in FDA, Regulatory Affairs, Regulatory Strategy, Regulatory Submissions
Tagged Cato Research, FDA, guidance
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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
Posted in Cato Research, Drug Development, FDA, Regulatory Affairs, Uncategorized
Tagged Cato Research, drug development, FDA, guidance, regulatory affairs
Comments Off on FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies
