SQA

JUNE 10, 2021

The new regulation, RDC 478/2021 , repeals economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for which economic monitoring will be required. FDA plant inspection and pay $50 million in fines and forfeiture. 10 May 2021.

COVID-19 52

COVID-19 FDA COVID-19 Vaccine Compliance 52

Hall Render

MAY 31, 2024

workers to be hit by biotech’s latest layoffs Maryland hospital systems differ over medical waste incinerator’s violations UMMC doctors will decide whether to unionize in a vote next month With $300K, Johns Hopkins team to create drug supply dashboard Maryland Hospital Cleared for $3.25 healthcare workforce finds lack of diversity St.

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

Drug & Device Law

DECEMBER 4, 2023

Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. 341 (2001).

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

JUNE 6, 2022

Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.” The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . .

FDA 59

FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

MARCH 22, 2022

The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval. While it mentions marketing and presentations made to doctors, the complaint “does not specifically allege how any of these marketing efforts reached [plaintiff’s] pediatrician.” Albrecht , 139 S.Ct.

Fraud 59

Fraud FDA Doctors 59

Drug & Device Law

MAY 26, 2022

They also had to have been made between the May 2006 PMA approval and the June 2007 implant, and been relied upon by the implanting surgeon or the plaintiff. But it was consistent with the rate in the approved IFU at the time and plaintiff had no evidence that she or her doctor relied on the undifferentiated rate.

Fraud 59

Fraud FDA Doctors 59