SQA

APRIL 12, 2023

The actions are part of the investigative process that the Agency and the National Health Surveillance System (SNVS) are conducting to identify deviations in the market and the cause of several adverse events reported by users of this type of product. To date, Pfizer has not received reports of any adverse events related to this recall.

FDA 40

FDA Compliance Pharmaceutical Industry 40

HIT Consultant

OCTOBER 27, 2022

Research from ESG validates that security professionals are turning to Zero Trust en masse – 90 percent of survey respondents stated that advancing Zero Trust strategies is one of their top three security priorities this year. The rallying cry in security now is to find solutions that effectively limit the impact of ransomware attacks.

Ransomware 52

Ransomware FDA Hospitals Doctors 52

Drug & Device Law

NOVEMBER 2, 2022

We certainly do not agree with the dissent to the denial of rehearing en banc in California Chamber of Commerce v. The Council sought rehearing en banc, which was denied by the Ninth Circuit. And yet the fact is that the Ninth Circuit more often than not gets things right. But it is a fun read. .

Governance 52

Governance 52

Drug & Device Law

FEBRUARY 25, 2022

allegations of failure to report adverse events to the FDA. The defendant first sought PLAC’s help on en banc rehearing, after suffering a loss on admission of expert testimony that we considered to be the worst decision of 2021. The appeal remains pending. 19-2899 (8th Cir. filed Sept.

FDA 59

FDA 59

Drug & Device Law

DECEMBER 29, 2023

2023) (en banc) (no presumption against preemption; “force of law” of agency ruling a non-issue in express preemption) ( here ); In re Ford Motor Co. The linchpin of the plaintiffs’ claims in this MDL was an internal corporate memo that concluded, under certain conditions, a particularly dangerous adverse event could occur.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

JANUARY 15, 2024

Common allegations of this sort are “ failure to test ,” “ failure to recall ,” “ failure to report ” adverse events to the FDA, and “ per se ” liability for purported FDCA violations. 2009) (en banc), decided before Tincher adopted consumer expectations as a Pennsylvania design defect test. Dana Cos. , 2d 943 (Pa.

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

MAY 16, 2022

2019) (en banc) (“ABA”). In any event, for a state (or a private party) to characterize the carcinogenic potential of anything as “known,” where science showed anything but, was fallacious. City & County of San Francisco , 916 F.3d 3d 749 (9th Cir. And lo it has come to pass. In California Chamber of Commerce v. 4th 468 (9th Cir.

Governance 59

Governance FDA 59

Drug & Device Law

SEPTEMBER 5, 2023

2017) (en banc) (“In determining the meaning of an express pre-emption provision, we apply no presumption against pre-emption, and we ‘focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.’”) Mentor Worldwide, LLC , 2019 WL 4038218 at *6 (C.D. Air EVAC EMS, Inc. , 1 (4th Cir.

Medicaid 64

Medicaid Medicaid Medicare Medicare 64

Drug & Device Law

JANUARY 13, 2022

. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown that Massachusetts recognizes a duty to submit such reports. Earlier this week, the First Circuit side-stepped the question of whether Massachusetts recognizes a duty to submit adverse-event reports to the FDA.

FDA 45

FDA Hospitals 45