Category Archives: FDA

New FDA Guidances for February 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 February 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more … Continue reading

Posted in Cato Research, FDA, Medical Research | Tagged , , | Leave a comment

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

Posted in Cato Research, FDA, Medical Research, Regulatory Strategy, Regulatory Submissions | Tagged , , , | Comments Off on New FDA Guidances for January 2017

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

Posted in Cato Research, Clinical Trials, FDA, Regulatory Strategy, Regulatory Submissions, Uncategorized | Tagged , , | Comments Off on New FDA Guidances for December 2016

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

Posted in Cato Research, Drug Development, FDA, Medical Research, Regulatory Strategy, Regulatory Submissions | Tagged , , | Comments Off on New FDA Guidances for October and November 2016

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

Posted in Cato Research, FDA, Medical Research, Rare Diseases | Tagged , , , | Comments Off on NORD Summit 2016 Highlights