Features

8 May 2012

ClinicalTrials.gov: Requirements and Implementation Strategies

By Elaine Wong, MS, and Rebecca Williams, PharmD, MPH

The Food and Drug Administration Amendments Act of 2007 (FDAAA) established a requirement for certain clinical trials to be registered at trial initiation and to report summary results after trial completion in the public registry and results database called ClinicalTrials.gov.  This law is intended to facilitate enrollment in clinical trials, allow for tracking of the progress of such trials and address problems with the lack of timely dissemination of research findings. This article discusses key considerations, helpful hints and some lessons learned to help meet the requirements of FDAAA as well as the trial registration policy of the International Committee of Medical Journal Editors (ICMJE). [Read More...]

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24 April 2012

Regulatory Environment Changes Affect REMS

By Elaine Taylor and Kiley DePolo

One US Food and Drug Administration (FDA) requirement that has undergone an important change is the requirement for inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies (REMS). A recent guidance (November 2011) reduced the need for a REMS when a medication guide is the only REMS element. [Read More...]

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