Pharma Defeats Biotech Push for Rapid Approval Program

Biotechs have been pushing to innovate the FDA’s current approval process for orphan drugs so as to enable faster clinical assessment and time to market of their drugs in development. Proposed changes include the use of pharmacodynamic biomarkers to determine drug efficacy and FDA evaluation of early trial results in the review process. Opposition from big pharma, citing safety concerns, is expected to result in a compromise plan to be presented to Congress later this year.

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