Drug Master Files (DMFs) in the United States, Canada, and European Union
By Amy S. Blawas, Ph.D., R.A.C., Associate Director of Pharmaceutical Development, Senior Scientist Cato Research Ltd. Recently, Cato Research has experienced an increased client activity in filing and...
View ArticleTop Five Mistakes in Clinical Protocol Design
By Lisa R. Sanders, Ph.D., R.A.C., Sr. Clinical Scientist II at Cato Research Almost a Holy Grail for the pharma/biotech world, the perfect clinical study protocol requires no amendments, collects only...
View ArticleNew FDA Guidances for October 2014 & Critical Path Innovation Meetings
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 October are posted. In addition, upcoming Advisory...
View ArticleNew FDA Guidances for November 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 November, are posted. In addition, upcoming advisory...
View ArticleThe Clinical Study Monitoring Plan
By Genevieve Marchand, M.Sc., C.C.R.A., Senior Clinical Research Manager at Cato Research Every study is different and the clinical monitoring plan should therefore be tailored to each individual...
View ArticleNew FDA Guidances for December 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 December 2014, are posted. In addition, upcoming advisory...
View ArticleNew FDA Guidances for January 2015
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 January 2015, are posted. In addition, upcoming advisory...
View ArticleAuthoring for eCTD – Know the Requirements and Think Like a Reviewer
By Jessica Long, B.S., R.A.C., Regulatory Associate II/Submissions Specialist at Cato Research “Before you judge a man, walk a mile in his shoes.” ― Cherokee Proverb Judgment has nothing to do with...
View ArticleNew FDA Guidances for February 2015
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 February 2015, are posted. Two updates to the CDER Manual...
View ArticleFramework for Regulatory Oversight of Laboratory Developed Tests (LDTs)
Dr. Jack Snyder, RAC, DABT, CPI, CPE CATO Research Washington “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory...
View ArticleNew FDA Guidances for March 2015
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 March 2015, are posted. Two updates to the CDER Manual of...
View ArticleNew FDA Guidances for April 2015
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 April 2015, are posted. In addition, upcoming advisory...
View ArticleNew FDA Guidances for May 2015
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 May, are posted. In addition, upcoming advisory committee...
View ArticleNew FDA Guidances for June 2015
By Brant Hamel, Ph.D. and Sheila Plant, Ph.D., R.A.C., Regulatory Scientists at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in June 2015, are posted. In addition, a...
View ArticleUsing a Clinical Trial Management System (CTMS) to Streamline Investigator...
by Sonya Cato, MS, Cato Research CTMS Administrator A key feature of Cato Research’s clinical trial management service is the administration of investigator payments. Multicenter clinical trials...
View ArticleNew FDA Guidances for July 2015
By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in July 2015, are posted. In addition, upcoming advisory committee...
View ArticleNew FDA Guidances for August 2015
By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in August 2015, are posted. In addition, upcoming advisory committee...
View ArticleMacaw, Beagle, or Python? How to Choose the Best Vendor for Your...
By: Margaret Schubert, Sr. Investigational Product Specialist, Compliance Specialist, Cato Research What if you were looking for a new pet? Would you simply go to the internet and pick out the first...
View ArticleNew FDA Guidances for September 2015
By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in September 2015, are posted. In addition, upcoming advisory committee...
View ArticleOne and Done: Are single pivotal studies the new norm in cancer therapeutics?
By Leanna Gentry, Ph.D., Fellow at Cato Research Clinical trials are a lengthy and costly component of drug development, with the vast majority of drugs failing to ever get to patients. Often, the...
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