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Category Archives: Clinical Trials
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 Cato Research, FDA, guidance
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Transparency Initiatives at Health Canada
By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy for Cato Research Canada. As part of the Regulatory Transparency and Openness Framework (http://www.hc-sc.gc.ca/home-accueil/rto-tor/index-eng.php), Health Canada has committed to provide greater transparency and openness to further strengthen trust in their … Continue reading
Posted in Canadian Regulatory Affairs, Cato Research, Clinical Trials, Drug Development, Health Canada
Tagged Cato Research, clinical research, Health Canada
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New FDA Guidances for September 2016
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 2016, are posted. In addition, upcoming advisory committee meetings to be held in the next month … Continue reading
Posted in Cato Research, Clinical Trials, Drug Development, FDA, Medical Research, Regulatory Strategy, Regulatory Submissions
Tagged Cato Research, clinical trials, drug development, FDA, guidance
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New FDA Guidances for August 2016
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 August 2016, are posted. One recent CDER Manual of Policies and Procedures (MAPP) regarding a change in … Continue reading
Posted in Cato Research, Clinical Trials, Drug Development, FDA, Medical Research, Regulatory Strategy, Regulatory Submissions
Tagged Cato Research, clinical trials, CROs, FDA, guidance
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New FDA Guidances for July 2016
By Yuka Fukushima, Regulatory Associate & Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from July 2016, are posted. In addition, upcoming advisory committee meetings to be held are also listed below … Continue reading
Posted in Clinical Trials, Drug Development, FDA, Medical Research, Regulatory Strategy, Regulatory Submissions
Tagged clinical research, clinical trials, drug development, FDA, guidance
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