Rare Disease Part 3: Balancing Genetics and Ethics in the Management of Rare Diseases - Changes in Regulatory Approval Pathways for Rare Diseases: A New Perspective

Barbara Binzak Blumenfeld, a shareholder in the FDA & Biotechnology practice group in Washington, DC, was a panelist at a Women in Bio event on April 20 in San Diego.  The event, “Rare Disease Part 3:  Balancing Genetics and Ethics in the Management of Rare Diseases,” attracted dozens of individuals from the southern California life sciences community.  Barbara’s presentation, “Changes in Regulatory Approval Pathways for Rare Diseases:  A New Perspective,” provided the legal framework for traditional new drug approvals, and discussed how rare disease drug development presents challenges and opportunities when working within this framework and with FDA.

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