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.

Public Health 313

Public Health FDA Bioethics Governance 313

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.

FDA 176

FDA Bioethics Public Health Governance 176

Bill of Health

JANUARY 7, 2022

Over the summer of 2021, concern grew that the vaccines were not providing the near-perfect protection against symptomatic disease and transmission that had first emboldened the administration to jettison other public health measures. Ultimately, both the FDA and CDC gave their blessing to boosters.

Public Health 339

Public Health FDA Governance COVID-19 Vaccine 339

Bill of Health

MARCH 7, 2024

Note: FDA approval for at least one indication is necessary for other “off-label” uses of the drug. You need one FDA approval to open the door to other off-label uses. Remember — no other psychedelic is FDA-approved ( yet ). Leveraging Public Opinion to Serve Public Health Again, this is not necessarily problematic !

FDA 111

FDA Telemedicine Public Health Doctors 111

Bill of Health

SEPTEMBER 28, 2023

Pressure from Senator Bernie Sanders, Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee seems to have catalyzed the administration to make this move. It is unlikely that the removal of a reasonable pricing condition on products funded by the federal government contributed to an increase in CRADAs.

COVID-19 205

COVID-19 COVID-19 Vaccine Pharmaceutical Industry Governance 205

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.

Governance 317

Governance Bioethics FDA Public Health 317

Health Populi

SEPTEMBER 8, 2021

The Pew Trusts recently discussed prospects for the FDA to regulate AI in health care. Building a nutrition label for health equity – learning from MITRE . Questions about the ethics and governance of AI in health are being posed globally.

FDA 68

FDA Governance Fraud World Health 68