FDA Docket for REMS Assessments Receives Joint Response from ParagonRx International LLC and BioTrak Research

Published: Jun 11, 2012

NEWARK, Del.--(BUSINESS WIRE)--On May 3, 2012, FDA released an Issue Paper addressing the need for improvement and standardization of REMS assessments focusing on the use of surveys to assess healthcare professionals’ and patients’ knowledge and understanding of medication risks titled, Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge. ParagonRx, an inVentiv Health company specializing in Safe Use Programs, along with BioTrak Research submitted a response to FDA’s Issue Paper on June 5, 2012.

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