Tag Archive: clinical trials

Jul 06

FDA Revises Guidance on Special Protocol Assessments

By Harsh Sancheti, MSPS, MSRS, Ph.D., Medical Writer at Cato Research and Joanne McNelis, Ph.D., Scientist at Cato Research   FDA Revises Guidance on Special Protocol Assessments What is a Special Protocol Assessment (SPA)? SPA is a process where a study sponsor and the FDA reach agreement on the critical components of a stability protocol, …

Continue reading »

May 31

Cato Research is Hiring… Join our team!

Check out our available positions: http://ow.ly/ER9o300L6cf

May 24

Looking for a FDA Breakthrough Therapy Designation (BTD)? Utilizing the Preliminary BTD Advice System Might be USEFUL – or NOT

By Harsh Sancheti, MSPS, MSRS, Ph.D., Medical Writer at Cato Research Looking for a FDA Breakthrough Therapy Designation (BTD)? Utilizing the Preliminary BTD Advice System Might be USEFUL – or NOT The Breakthrough Therapy Designation (BTD) process implemented by the US FDA facilitates expedited regulatory review of a drug candidate intended to treat a serious …

Continue reading »

May 16

New 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 committee meetings to be held are also listed below with a link to more information.   Special Interest Guidances/Information Date Posted Assay Development and Validation for …

Continue reading »

Mar 16

Jump 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 reporting requirements. Many US-based sponsors have opted for the Annual Report format when it comes to their IND (sections 1.13.1 to 1.13.14 of the IND; …

Continue reading »

Jan 27

The 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 advise the FDA commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. This marks a major …

Continue reading »

Jan 12

New 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 meetings to be held are also listed below with a link to more information.   Special Interest Guidances/Information Date Posted Public Notification of Emerging Postmarket …

Continue reading »

Dec 09

Toxicological/Safety Evaluation of Herbal Supplements and Botanical Combinations

Toxicological/Safety Evaluation of Herbal Supplements and Botanical Combinations by Harsh Sancheti, Ph.D., Medical Writer at Cato Research Plants all around us show an astonishing ability to grow in some of the most taxing conditions, fight deadly viruses (without even a leaf moving – quite figuratively), provide nutrition and food sources, and have been historically used …

Continue reading »

Dec 01

New 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 meetings to be held are also listed below with a link to more information. Special Interest Guidances/Information Date Posted Certification Process of Designated Medical Gases …

Continue reading »

Nov 23

Considerations for Early-Phase Clinical Trial Design for Cell and Gene Therapy Products

Considerations for Early-Phase Clinical Trial Design for Cell and Gene Therapy Products By Michelle Villasmil, Ph.D., Scientist at Cato Research Despite the potential benefits of cell and gene therapy (CGT), early experiences with some CGT products have presented considerable risks to patients. These risks include possible prolonged biological activity after administration, a high likelihood for …

Continue reading »

Older posts «

» Newer posts