Bill of Health

SEPTEMBER 13, 2023

These five students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from Harvard Law School. His current research focuses on tensions between the patent incentive system, the FDA approval process, and insurance carriers. Vincent Joralemon is a law student (J.D.

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Bill of Health

SEPTEMBER 16, 2024

2025) is Assistant Professor at Brown University’s Department of Psychiatry and Human Behavior and a master’s candidate at Harvard Medical School’s Center for Bioethics. Her research interests include genetics, environmental health sciences, novel biotechnologies, and the FDA regulatory process. Zain Khalid (M.B.E Jessica Samuels (J.D./MPH

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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.

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Bill of Health

DECEMBER 6, 2024

US Legal Requirements for Quantum-Powered Medical Devices In the United States, some quantum-powered medical devices may be governed under the existing FDA regulatory framework. Foster Institutional Plasticity: Evolve institutions like the FDA and EMA to accommodate quantum technologies.

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Jane Sarashon

FEBRUARY 13, 2025

doctors would want to see increased oversight in terms of regulatory actions that could increase their trust in adopting AI tools — such as oversight from the FDA, the top-ranked regulatory action noted in the survey among nearly one-half for “first” and by another 18% for “second” regulatory desire. First, U.S.

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Health Populi

APRIL 1, 2025

On the supply side of health care and especially public-sector health care services and public health systems and information, I publish this post on a day when major cuts to the CDC, the FDA, and other health agencies are announced.

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Bill of Health

JUNE 12, 2024

The practicality I’ve noticed over the years is that no matter what we aim at, there’s the very severe, shorter-term FDA trial. GC: It has piqued my interest for many years. If you look at gene therapies, I’ve been kind of a vocal opponent and advocate of gene therapies for rare diseases.

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Health Populi

AUGUST 12, 2021

In this Rise of the Medical Machines, the major risks for health care organizations were that, 68% of health care deployments had more than 10 FDA recalls. . “During the chaos and confusion, threat actors launched cyberattacks,” Ordr observed in the wake of the public health crisis.

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Bill of Health

NOVEMBER 18, 2022

By Aparajita Lath. The Truth Pill , authored by Dinesh Thakur and Prashant Reddy , is a monumental work that convincingly shows that drug regulation is but a myth in India. In their investigative style, the authors explain drug regulation in India through the lens of history, both Indian and global.

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Bill of Health

FEBRUARY 26, 2024

In December 2022, the FDA Modernization Act 2.0 formally ended the FDA’s 1938 mandate to use animal models and opened the doors for organoids to be used as a full replacement for animals in pre-clinical trials. Would they classify as a medical device or biologic under FDA guidelines, or perhaps as a combination product?

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Bill of Health

MARCH 28, 2022

Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2. By James Lytle. Recent guidance from the U.S.

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Bill of Health

AUGUST 28, 2024

I think that regardless of how ambitious you are, you need to play by the FDA rules and ensure complete compliance with the established clinical pathways. Some of these targets are also implicated in several hallmarks of aging, so I do hope that these drugs will work in aging as well.

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Health Populi

JUNE 29, 2021

The FDA’s approval of the first therapy to treat Alzheimer’s Disease in over twenty years brought attention to a not-yet-convened debate of U.S. The FDA regulatory process and aftermath. health care costs and spending, innovation, and return-on-the-investment (as well as “for whom” do the returns accrue).

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Medicare Medicare FDA Bioethics 62

Jane Sarashon

JULY 27, 2022

Apple has progressed its digital health innovations for cardio fitness as an indicator of overall health, with high and low heart rate notifications, the ECG app coupled with the Apple Watch, irregular rhythm notifications, and an FDA-cleared AFib History feature.

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Bill of Health

NOVEMBER 30, 2022

Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public. State pharmaceutical bans and restrictions — which are often medically unnecessary and instead based largely on policymakers’ moral and political views — impede the FDA’s mandate to protect and promote the public health.

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Bill of Health

DECEMBER 14, 2022

Food and Drug Administration (FDA). For example, physicians and companies offering cytoplasmic and mitochondrial transfer have received Untitled Letters from the FDA. After receiving the letters, these individuals and entities have ceased to provide these techniques in the United States.

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Bill of Health

SEPTEMBER 28, 2023

By Nikhil Chaudhry and Reshma Ramachandran Earlier this month, the Department of Health and Human Services announced that it had successfully included a reasonable pricing provision in a $326M investment contract with Regeneron for development of a next generation monoclonal antibody therapy for COVID-19.

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Health Populi

JANUARY 18, 2021

FDA-cleared, the “button” is streamlined as a “stick it and forget it” medical device that can gathered up to 30-days’ worth of vital signs on the patient to whom the device is “stuck.” The BioIntelliSense device garnered a CES 2021 innovation award.

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Bill of Health

DECEMBER 9, 2024

artwork by Daiara Tukano by Daiara Tukano and Maria Fernanda Gebara Last June, we had the honor of speaking at Law and Policy of Psychedelic Medicine, the 2024 Annual Conference hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. You can watch our panel here.

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Health Populi

SEPTEMBER 8, 2021

The Pew Trusts recently discussed prospects for the FDA to regulate AI in health care. Scaling and continuous feedback, continuing to adapt the models based on real-life experience that might have been overlooked in the original design.

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Bill of Health

MAY 28, 2024

Schedule 3 drugs must be approved by the Food and Drug Administration (FDA,) prescribed by a doctor, and distributed by a pharmacy. Congress must specify that FDA’s jurisdiction over cannabis should be no more than that over alcohol and designate cannabis in food as “generally recognized as safe.” Victoria Litman M.Div, J.D.,

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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 ). However, the U.S. none can ( legally ) provide psilocybin, LSD, or MDMA ( yet ).

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Bill of Health

JUNE 15, 2024

Without Chevron deference, how will agencies relying on scientific expertise, like the FDA, CDC, and NOAA, function? Indeed, FDA Commissioner Robert Califf appears to be on nail-biting watch. Indeed, FDA Commissioner Robert Califf appears to be on nail-biting watch. Current predictions from court-watchers are dire.

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Bill of Health

JANUARY 7, 2022

The American booster push was controversial, because the scientific evidence on the need for and effectiveness of boosters was limited, and the White House exerted an unprecedented level of pressure on the FDA and CDC’s ‘independent’ scientific review processes. Ultimately, both the FDA and CDC gave their blessing to boosters.

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Health Populi

JANUARY 27, 2025

These sites include those under the Department of Health and Human Services umbrella including the NIH and the FDA — the latter of which informs us every day on food safety issues — say, eggs, milk, produce, and deli meats all of which have been top-of-mind in recent months.

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US Department of Health and Human Services Public Health FDA Governance 62

Bill of Health

DECEMBER 9, 2024

artwork by Daiara Tukano by Daiara Tukano and Maria Fernanda Gebara Last June, we had the honor of speaking at Law and Policy of Psychedelic Medicine, the 2024 Annual Conference hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. You can watch our panel here.

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Bill of Health

FEBRUARY 10, 2025

Food and Drug Administration (FDA) to terminate pregnancy through 70 days gestationto remain widely available without the reimposition of restrictions on its access. Importantly, however, a ruling on standing only means that these particular plaintiffs lacked standing to sue the FDA. About the author Allison M.

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