Bioethics FDA Governance Presentation 
Bill of Health
APRIL 24, 2023
Regulatory and patent exclusivity periods govern the timing of generic entry, and because market share and revenue is often quickly lost upon market entry of generic drugs, extending market exclusivity for any duration can be extremely profitable. Glenn Cohen’s Health Law Policy, Bioethics, and Biotechnology Workshop at HLS.
Bill of Health
JANUARY 7, 2022
The “tools” stood for individual choices based on personal risk tolerance rather than elements of regulatory frameworks to be pursued by various levels of government. In response to the perceived overreach, two high-level FDA vaccine regulatory officials resigned in protest. Let’s address each of these three tools.
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