Biogenerics Bill From Pallone/Deal Is A Mere 98 Questions Away From Consensus
House Energy & Commerce Health Subcommittee staffers will need an extra-large spread sheet to find the consensus in stakeholder positions on follow-on biologics legislation
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FDA's Chief Scientist will continue to push for outside academic collaborations during his "short time" atop the agency; fall letter on follow-on biologics could draw closer reading.
While urging Congress to write legislation that allows FDA to decide which scientific data are needed to approve follow-on biologics, comments from the American Society of Clinical Oncology to a House subcommittee note that clinical trials will be necessary for most FOBs