New FDA Guidances for October 2015
By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in October 2015, are posted. In addition, upcoming advisory committee...
View ArticleNew FDA Guidances for November 2015
By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in November 2015, are posted. In addition, upcoming advisory committee...
View ArticleNew FDA Guidances for December 2015
By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in November 2015, are posted. In addition, upcoming advisory committee...
View ArticleThe FDA Wants To Hear Patients’ Voices
The FDA Wants To Hear Patients’ Voices by Joanne McNelis, Ph.D., Scientist at Cato Research In September the FDA announced the creation of its first-ever Patient Engagement Advisory Committee (PEAC) to...
View ArticleNew FDA Guidances for January 2016
Special Interest Guidances/Information Date Posted Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices– Draft Guidance 26-Jan-2016 Postmarket Management of...
View ArticleJump on the Development Safety Update Report (DSUR) Bandwagon!
By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Clinical Scientist, Cato Research Canada. If you have an open Investigational New Drug application (IND) then you are all too familiar with the periodic...
View ArticleNew FDA Guidances for April 2016
By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from February-April 2016, are posted. In addition, upcoming advisory...
View ArticleCato Research is Hiring… Join our team!
Check out our available positions: http://ow.ly/ER9o300L6cf The post Cato Research is Hiring… Join our team! appeared first on Ask Cato Research. Related posts: Credentialing Developments at Cato...
View ArticleA Brief Overview of the Use of Electronic Informed Consent in Clinical...
by Rachael Gregg, B.A., Cato Research Clinical Research Associate A Brief Overview of the Use of Electronic Informed Consent in Clinical Investigations The United States Food and Drug Administration...
View ArticleNew 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...
View ArticleNew 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...
View ArticleThe Current Implementation of the Drug Supply Chain Security Act (DSCSA)...
What is the Drug Supply Chain Security Act (DSCSA)? In November 2013 the Drug Quality and Security Act (DQSA) was signed into law with the intent to decrease incidence of counterfeit, falsified, or...
View ArticleNew 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...
View ArticlePrecision 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...
View ArticleNew 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...
View ArticleTransparency 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...
View ArticleWhat’s New Health Canada? Jan 2017
By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy, and Christine Straccini, B.Sc., Regulatory Associate; Cato Research Canada What’s New in: Therapeutic Products...
View ArticleA New Expedited Review Designation: Regenerative Advanced Therapy
By Michelle Villasmil, Ph.D., RAC (U.S.), Regulatory Scientist at Cato Research One of the many changes brought by the 21st Century Cures Act is the new expedited review designation entitled...
View ArticleCANCER IMMUNOTHERAPY: A NEW HOPE
By Reshma Jagasia, Ph.D, Scientist at Cato Research The current standard of care for cancer treatment is surgery, chemotherapy, and radiation therapy – a standard that has persisted for decades. These...
View ArticleNew FDA Guidances for March and April 2017
By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, and Manual of Policies and Procedures (MAPPs) of interest,...
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