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 …
Category Archive: Clinical Trials
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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, …
