Patient safety should be addressed in follow-on biologics measure
Congress should ensure that patient safety and medical efficacy are prioritized in a health reform measure that allows the use of follow-on biologics, Dr. David B. Nash of the Jefferson School of Population Health writes in The Hill. Rather than just debating data exclusivity for FOBs, lawmakers should also specify rules on testing these drugs and consider requiring post-market surveillance to avoid "unintended consequences" that compromise patient safety, Nash writes.
Hill, The
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This story published in BIO SmartBrief on 11/04/2009
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