Category Archives: FDA

New FDA Guidances for January 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in January 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more … 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 October and November 2016

By Michelle Villasmil, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in October and November 2016 are posted. In addition, upcoming advisory committee meetings to be held in the next month … Continue reading

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NORD Summit 2016 Highlights

By Kimberley Cummings, Ph.D., RAC (US), Vice President, Scientific & Regulatory Strategy and Operations Cato Research   The National Organization for Rare Disorders (NORD) held their annual Rare Diseases and Orphan Products Breakthrough Summit in Arlington, VA on October 17th … Continue reading

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Precision Medicine and the FDA

by Reshma Jagasia, Ph.D., Scientist at Cato Research “Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their treatments as best they can to individuals. You can match a blood transfusion to a blood … Continue reading

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