Tag Archives: clinical research

Toward Compliance 2.0 : When your Pill is Connected to your Smartphone

By: David Hamel, Fellow Scientist Cato Research Canada The FDA approval of Abilify MyCite (aripiprazole tablets with sensor; by Otsuka) on 13 November 2017 for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I … Continue reading

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A 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 Regenerative Advanced Therapy (with the unfortunate acronym of RAT). FDA … Continue reading

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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

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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

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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Electronic Informed Consent in Clinical Investigations The United States Food and Drug Administration (FDA) released a draft guidance “Use of Electronic Informed Consent … Continue reading

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