Bioethics FDA Governance 
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
SEPTEMBER 22, 2022
These five students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from across Harvard. Sarah Gabriele is a second year Master of Bioethics candidate at Harvard Medical School. We are excited to welcome a new group of Student Fellows to the Petrie-Flom Center family. Louis (USA).
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Bill of Health
NOVEMBER 18, 2022
In fact, before publishing the book, the authors petitioned the government, highlighting glaring regulatory issues, but the government turned a blind eye. The book relies on primary sources of information — mainly government reports, judicial decisions, and government data.
Bill of Health
APRIL 26, 2022
To navigate the myriad interests and stakes involved in creating federal psychedelic policy, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School convened a virtual panel discussion with three leading psychedelic policy advocates. By James R. A full video of the event is available below.
Bill of Health
NOVEMBER 30, 2022
Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public. healthcare system, representing just one example of “healthcare federalism” — the division of power between the federal and state governments in the regulation of health care. After Dobbs , U.S.
Bill of Health
SEPTEMBER 28, 2023
Such a provision could prevent the public from paying twice for publicly-funded medical products—first through their taxes subsidizing government funded research and development, and second to procure the product in an inflated U.S. pharmaceutical market. Moreover, the NASDAQ Biotechnology Index increased by 374% from 1995 to 2000.
Bill of Health
JUNE 15, 2024
Chevron holds that “a government agency must conform to any clear legislative statements when interpreting and applying a law, but courts will give the agency deference in ambiguous situations as long as its interpretation is reasonable.” Indeed, FDA Commissioner Robert Califf appears to be on nail-biting watch. And does it matter?
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