By
Jaclyn Jaeger2021-09-07T19:08:00
The U.S. Food and Drug Administration’s “intended use” final rule reaffirms the agency’s wide latitude of discretion in establishing an off-label use case against pharmaceutical and medical device companies.
2025-01-15T19:05:00Z By Oscar Gonzalez
The U.S. Food and Drug Administration announced Wednesday it has revoked authorization for color additive Red No. 3 from food, beverages, and drugs. Health concerns over dye have existed since it was banned from cosmetics in 1990 after it was found that large doses led to the development of cancer ...
2025-11-26T19:34:00Z By Adrianne Appel
One of the largest wound care practices in the nation and its founder have agreed to pay $45 million and be subjected to third-party monitoring, to settle allegations that the business intentionally overbilled Medicare by priming its electronic medical records system to do so.
2025-11-26T19:21:00Z By Tom Fox
AI decisions are only defensible when the reasoning behind them is visible, traceable, and auditable. Explainable AI delivers that visibility, turning black-box outputs into documented logic that compliance officers can stand behind when regulators, auditors, or stakeholders demand answers.
2025-11-26T19:20:00Z By Oscar Gonzalez
The U.S. Federal Deposit Insurance Corporation issued a final rule to change the leverage capital requirements for both large and community banks. The agency said the modification will ”reduce disincentives a banking organization may have to engage in lower-risk activities.”
2025-11-25T21:55:00Z By Ruth Prickett
Suppliers to the U.K. critical infrastructure will face new regulations to ensure they are protected from cyberattacks. The Cyber Security and Resilience Bill, introduced on November 12, also raises penalties for breaches and expands regulator powers to label certain suppliers as critical.
2025-11-24T20:34:00Z By Adrianne Appel
Telecommunication companies are now on the honor system to protect their networks from cyber attacks, following a Federal Communications Commission (FCC) vote that removed requirements that they harden their networks.
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