Healthcare Law Today

JANUARY 11, 2023

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

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FDA Governance Medicare Medicare 59

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The government is aiming for the revised framework to now apply from July 2025.

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Bill of Health

AUGUST 29, 2022

Some children may be unvaccinated by no choice of their own, but instead because of decisions made by parents, guardians, or state or local government officials. 2] E.g. , Racial Disproportionality and Disparity in Child Welfare , Dep’t Health & Hum. Bureau 1, 2 (2014); Robert B. Omicron Surge , Bloomberg (Dec. & Fams.,

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Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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SQA

AUGUST 2, 2021

ISO 18082:2014, Anesthetic and respiratory equipment – Dimensions of non-interchangeable screw-threaded (NIST) low pressure connectors for medical gases. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. Leveraging data to improve supply chain resilience.

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SQA

FEBRUARY 26, 2024

The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies.

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FDA Compliance COVID-19 Public Health 52

Kaiser Health News

JUNE 2, 2022

when the FDA approved mifepristone in 2000. Some legal and drug regulatory experts argue that because the FDA is the federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human drugs, states wouldn’t have the power to overrule its stamp of approval and outlaw the abortion pill.

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