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.

FDA 130

FDA Governance Compliance Bioethics 130

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.

Doctors 64

Doctors FDA Hospitals Bioethics 64

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.

Bioethics 100

Bioethics Pharmaceutical Industry FDA 100

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.

COVID-19 174

COVID-19 FDA Public Health Hospitals 174

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?

FDA 113

FDA Informed Consent Bioethics 113

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).

Medicare 62

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.

US Department of Health and Human Services 52

US Department of Health and Human Services Doctors Public Health COVID-19 52

Bill of Health

APRIL 24, 2023

Dmitry’s talk, “Evergreening: The FDA’s Role in the Creation of Balanced Rights for Pharmaceutical Improvements,” was developed into an article and published in the Iowa Law Review in 2019 titled “The More Things Change: Improvement Patents, Drug Modifications, and the FDA.”

Public Health 317

Public Health FDA Bioethics Governance 317

Bill of Health

DECEMBER 20, 2022

FDA Approval. Food and Drug Administration (FDA), which “ regulates the sale of medical device products (including diagnostic tests) in the U.S. ” Although it is questionable whether the FDA would ever approve the Sarco machine as a medical device, it turns out the FDA may not need to. .”

FDA 245

FDA Doctors Informed Consent Bioethics 245

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.,

FDA 214

FDA Bioethics Compliance Telemedicine 214

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.

FDA 240

FDA Licensing Bioethics 240

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.

Public Health 62

Public Health Electronic Medical Records Regulatory Compliance FDA 62

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.

FDA 220

FDA Bioethics Compliance 220

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.

Governance 321

Governance Bioethics FDA Public Health 321

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.

FDA 71

FDA Governance Fraud World Health 71

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.

US Department of Health and Human Services 77

US Department of Health and Human Services COVID-19 Electronic Medical Records Hospitals 77

Bill of Health

NOVEMBER 9, 2022

In Drugs and the FDA: Safety, Efficacy, and the Public’s Trust , oncologist Mikkael A. Sekeres centers his narrative on the controversial 2011 Avastin hearings , in which the FDA reconsidered and ultimately withdrew the breast cancer indication for Genentech’s Avastin drug. By Matthew Chun.

FDA 264

FDA Bioethics 264

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.

FDA 182

FDA Bioethics Public Health Governance 182

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 ).

FDA 113

FDA Telemedicine Public Health Doctors 113

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.

Public Health 340

Public Health FDA Governance COVID-19 Vaccine 340

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.

COVID-19 246

COVID-19 Public Health FDA Hospitals 246

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.

Bioethics 214

Bioethics Pharmaceutical Industry FDA 214

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.

FDA 208

FDA COVID-19 Vaccine COVID-19 Bioethics 208

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.

COVID-19 208

COVID-19 COVID-19 Vaccine Pharmaceutical Industry Governance 208

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.

Bioethics 221

Bioethics FDA Public Health Governance 221

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.

US Department of Health and Human Services 62

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

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.

Bioethics 130

Bioethics FDA Governance 130