Regulatory Roundup: Week of October 22, 2012

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FDA announces Coalition for Accelerating Standards and Therapies and Commissioner Hamburg comments on meningitis outbreak.

Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, announced on Oct. 24, 2012, in an FDA blog, the launch of the Coalition for Accelerating Standards and Therapies (CFAST), a partnership between FDA, the Clinical Data Interchange Standards Consortium (CDISC), and the Critical Path Institute (C-Path). The partnership intends to bring clinical data experts together to “develop data standards tailored to individual diseases and therapeutic areas” and provide opportunities to transform data from drug studies on specific diseases to get new therapies to patients quicker.

“Standardized data elements that are common to all clinical trials, such as age and gender, have been established using CDISC terminology. However, data elements that are unique for a particular disease or therapeutic area still need to be developed so that the data from multiple trials can be more easily grouped for reporting and analysis,” said Woodcock. “We believe that CFAST will provide an important resource for drug development and research that will result in enhancements in the evaluation of safe and innovative therapies for the public.”


FDA Commissioner Margaret A. Hamburg, MD, issued a statement on Oct. 24, 2012, in response to the fungal meningitis outbreak, stressing the importance of the partnership between federal, state, and local authorities in dealing with public health issues. "The FDA has been working closely with the CDC and public health officials in Massachusetts and other states to investigate the scope and cause of the outbreak. In fact, both agencies have been working hand-in-hand with our colleagues in every state affected by this outbreak," said Hamburg.