Bill of Health

DECEMBER 6, 2024

Devices must primarily comply with Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostic Medical Devices. 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.

FDA 182

FDA Governance Compliance Bioethics 182

Bill of Health

APRIL 24, 2023

Yet Dmitry Karshtedt held otherwise at the ASLME Health Law Professor’s Conference in Atlanta, GA in 2017. Glenn Cohen’s Health Law Policy, Bioethics, and Biotechnology Workshop at HLS. In each scenario, public health considerations drove the product switches and the FDA actively encouraged the development of reformulated products.

Public Health 317

Public Health FDA Bioethics Governance 317

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. million units with revenues of $4.5 billion.

COVID-19 174

COVID-19 FDA Public Health Hospitals 174

Bill of Health

DECEMBER 6, 2024

Devices must primarily comply with Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostic Medical Devices. 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.

FDA 130

FDA Governance Compliance Bioethics 130

Bill of Health

FEBRUARY 26, 2024

Much has been made of recently discussed CAR-T cell therapies for cancer , which have been around since 2017, and in-human sickle cell treatment Casgevy. In December 2022, the FDA Modernization Act 2.0 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

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

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