Regulatory Focus™ > News Articles > FDA to Hold Meeting on Modernizing Clinical Trials Regulation

FDA to Hold Meeting on Modernizing Clinical Trials Regulation

Posted 06 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is set to hold a two-day meeting 23-24 April 2012 on how best to modernize the regulations, policies and practices associated with conducting clinical trials.

FDA notes that "effective regulatory oversight is needed to ensure that human subjects are protected and resulting clinical trial data are credible and accurate."

In response to complaints that current clinical trial regulations are inefficient, costly and outdated, FDA plans to work with the public to develop "innovative methods and technological advances to improve clinical trial quality."

"The Agency is involved in an effort to modernize the regulatory framework that governs clinical trials and approaches to good clinical practice (GCP)," writes FDA in the Federal Register posting. "The purpose of this hearing is to solicit public input from a broad group of stakeholders on the scope and direction of this effort, including encouraging the use of innovative models that may enhance the effectiveness and efficiency of the clinical trial enterprise."

Registrations for the meeting at due by 2 April 2012, and may be sent to ClinTrialPublicMt@fda.hhs.gov.


Read more:

FDA - Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice; Public Hearing; Request for Comments

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