Tag Archive: clinical trials

Aug 18

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 with a link to more information. Special Interest Guidances/Information Date Posted General Wellness: Policy for …

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Aug 17

A Brief Overview of the Use of Electronic Informed Consent in Clinical Investigations

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Electronic Informed Consent in Clinical Investigations The United States Food and Drug Administration (FDA) released a draft guidance “Use of Electronic Informed Consent in Clinical Investigations” in March 2015 that outlines recommendations for clinical investigators, sponsors, and institutional …

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Jul 13

New FDA Guidances for May and June 2016

By Yuka Fukushima, Regulatory Associate & Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from May-June 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 Early Clinical Trials With …

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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, …

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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 …

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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 …

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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; …

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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 …

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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 …

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