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For Industry

Public Meeting: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies


FDA has extended the deadline for submitting comments to the docket that will be considered in the report on REMS standardization to Friday, September 20, 2013.

The Food and Drug Administration (FDA) is announcing a 2-day public meeting to obtain input on issues and challenges associated with the standardization and assessment of risk evaluation and mitigation strategies (REMS) for drug and biological products. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into, and reduce their burden to, the existing and evolving health care system. As part of the PDUFA commitments, FDA will also seek to develop evidence-based methodologies for assessing the effectiveness of REMS.

To obtain input from stakeholders about REMS standardization and evaluation, FDA will hold a public meeting to give stakeholders, including health care providers, prescribers, patients, pharmacists, distributors, drug manufacturers, vendors, researchers, standards development organizations, and the public an opportunity to provide input on ways to standardize and assess REMS.

The docket for written comments will remain open indefinitely. However, submit comments no later than September 16th to be considered for FDA's report of its findings on standardization and identification of priority projects.


July 25, 2013 - 8:30 a.m. to 4:30 p.m.

July 26, 2013 - 8:30 a.m. to 4:30 p.m.
FDA’s White Oak Campus
10903 New Hampshire Avenue
Building 31 (Great Room - 1503)
Silver Spring, MD 20993
Please send any correspondence regarding the meeting to:
Further information regarding the REMS Integration Initiative can be found at: 


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