Category Archive: Clinical Trials

Feb 08

Big Data, RWE, and AI Made Simple

By Hadas Jacoby Adani, Marketing Manager, Israel, Cato Research Technology is slowly but surely penetrating the healthcare industry in general and the clinical trials sector in particular. New and advanced solutions offer a variety of possibilities aimed to both improving existing processes and creating new and more efficient ones. And on top of all stands …

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Dec 04

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

By Denis Okumu, Ph.D., Postdoctoral Fellow at Cato Research Ltd Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Section 801 of the Food and Drug Administration Amendment Act of 2007 (FDAAA) amended section 402(j) of the Public Health Service (PHS) Act[1] to require that responsible parties and/or submitters of certain applications and submissions to …

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Aug 09

Medical Devices: Clinical Trials in South Africa – Part 1

By Nicola Main, Clinical Research Manager I, Clinical Trial Operations – Rest of World Cato Research   Medical Device Workshop at MCC – 13/14 July 2017 – Summary for SACRA Members This workshop provided supporting information and explanation of items contained in the various guidelines regarding medical devices. These guidelines are in the process of being …

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Jan 09

New FDA Guidances for December 2016

By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in December 2016 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest Guidances/Information Date Posted Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities …

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Jan 04

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 regulatory decisions. The Framework will: Help Canadians to better understand how and why decisions are …

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Oct 12

New 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 committee meetings to be held in the next month are listed below with links to more information.   Special Interest Guidances/Information Date Posted Q7 …

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Sep 12

New 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 and Procedures (MAPP) regarding a change in hard gelatin capsule shell suppliers is included.  In addition, upcoming advisory committee meetings to be …

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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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