Bill of Health

APRIL 4, 2024

Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.

FDA 282

FDA Regulatory Compliance Malpractice Health Insurance 282

Hall Render

MARCH 3, 2023

Arkansas looks to students to help Expanding medical residency programs may help curb physician shortage UAMS Receives $600,000 to Provide Post-Partum Contraceptive Devices in Little Rock, Fort Smith Baptist Health Opens New Critical Care Unit at NLR Hospital Why one state’s plan to unwind a Covid-era Medicaid rule is raising red flags CALIFORNIA Becerra (..)

Nursing Homes 40

Nursing Homes COVID-19 Nurses Hospitals 40

Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” FDA , 727 F. That’s why Buckman Co.

FDA 59

FDA Doctors Malpractice COVID-19 59

Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” FDA , 727 F. That’s why Buckman Co.

FDA 52

FDA Doctors Malpractice COVID-19 52

Drug & Device Law

AUGUST 8, 2022

Apparently, a fraudulent foreign-trained “doctor” treated the plaintiffs, none of whom claimed malpractice or any physical injury whatsoever. So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. Such power rests solely with the FDA.”

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

JUNE 7, 2022

The last provision cited by plaintiff’s side was one that allows the fact finder to consider evidence of compliance with regulations. Plaintiff argued this conflicted with the learned intermediary rule because the FDA requires warnings to consumers when manufacturers market drugs to consumers.

Doctors 69

Doctors FDA Informed Consent Malpractice 69

Drug & Device Law

APRIL 21, 2023

The patient sadly passed away after having 23 teeth removed and replaced (for those keeping score, that is more than two-thirds of a normal human complement of teeth), and his family sued for medical malpractice and product liability. That would be especially true in states where regulatory compliance is a defense or partial defense.

Informed Consent 59

Informed Consent Malpractice FDA Regulatory Compliance 59