Bill of Health

OCTOBER 31, 2024

government has discussed the potential adoption of a uniform FOP label, with Congress directing the Centers for Disease Control and Prevention and Institute of Medicine (IOM) to produce recommendations on the topic. Food and Drug Administration (FDA) is expected to propose new rulemaking on front-of-package labeling in 2024.

Public Health 100

Public Health FDA Governance Licensing 100

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. These products are widely used by Canadians.

FDA 40

FDA Compliance Licensing World Health 40

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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US Department of Health and Human Services FDA COVID-19 World Health 40

The Digital Health Corner

JUNE 14, 2017

According to most recent statistics from the Office of the National Coordinator, use of EHRs has increased from 20% in 2004 to 87% in 2015. I’d like to discuss what I believe are five areas of significant opportunity for quality technologies. EHRs were designed as documentation centers for billing and regulatory purposes.

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Patient Satisfaction Hospitals FDA Governance 87

Healthcare IT News - Telehealth

DECEMBER 16, 2020

In March, as states were issuing stay-at-home orders, the FDA published pandemic-specific guidance for trial sponsors, institutional review boards and investigators on how to ensure the safety of their trial participants and reduce risks to trial integrity, while sustaining compliance with good clinical practice.”

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COVID-19 Hospitals Doctors Health Insurance 214

SQA

AUGUST 2, 2021

ISO5356-1:2015, Anesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets. ISO 17510:2015, Medical devices – Sleep apnea breathing therapy – Masks and application accessories. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden.

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FDA COVID-19 Pharmaceutical Industry Hospitals 83

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. Health Care Issues for Children and Adolescents in Foster Care and Kinship Care , 136 Pediatrics e1131, e1132 (2015). [6] 3] Bell, supra note 99 at 26. [4]

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COVID-19 Vaccine COVID-19 Informed Consent Governance 130

HIT Consultant

NOVEMBER 29, 2022

Compounding the frustration among healthcare providers is the poor level of R&D investments governments are making which stalls progress. It has been approved by the United States Food and Drug Administration (FDA) and is currently a generic drug (e.g.,

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FDA Doctors Governance 98

Hall Render

DECEMBER 22, 2023

911 dispatchers couldn’t understand them OKLAHOMA Children’s hospital in Oklahoma second in country with new therapy technology OU Health receives federal grant to support telemedicine for rural stroke patients OREGON Legacy Health sells medical office building for $60.5M

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Nursing Homes Nurses COVID-19 Hospitals 40

Kaiser Health News

MAY 13, 2022

Data brokers trade in other types of information, such as location-tracking data for people who visited Planned Parenthood, which potentially could be purchased by law enforcement or government officials. It can depend on the company’s approach to subpoenas, she added. Some will fight them while others will not. “The U.S.

US Department of Health and Human Services 106

US Department of Health and Human Services HIPAA Governance Health Insurance 106

Hall Render

APRIL 21, 2023

Billion in Community Benefit in 2021 OhioHealth buys land in Canal Winchester – 3 miles from competitor’s ER Quipt Home Medical inks $26M stock deal with Beacon Securities, Canaccord Genuity Corp.,

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US Department of Health and Human Services COVID-19 Nurses Nursing Homes 40

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. at 349 (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance”). Medtronic, Inc. ,

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FDA Governance Nurses Hospitals 59

Drug & Device Law

SEPTEMBER 21, 2023

The parties’ contract required the supplier to deliver components that “meet FDA standards for medical devices.” The manufacturer claimed that the supplier breached the contract when it delivered components that, according to the manufacturer, violated the FDA’s Current Good Manufacturing Practices (CGMP) regulations. . § Ohio 2023).

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FDA Governance Compliance 59

Drug & Device Law

MAY 16, 2022

2015), took one on the chin recently in the Ninth Circuit at the hands of free speech under the First Amendment. Fortunately for limited government everywhere, the private group lost in CCoC – unanimously. as the FDA acknowledged the warning might be. . . . [W]hen Pepsico, Inc. , 3d 1045, 1062 (N.D. Here’s how. CCoC , 29 F.4th

Governance 59

Governance FDA 59

Drug & Device Law

APRIL 28, 2022

State and local government entities from very different parts of the country might want leeway in regulating things like the volume or time of demonstrations. Whereas those jurists who otherwise tout the importance of civil rights in our legal system may be inclined to afford local governments more deference in restricting speech.

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FDA Governance 59

Drug & Device Law

AUGUST 8, 2022

Furthermore, trade associations often serve to assist the government in areas that it does not regulate. 2015 WL 6393869 (S.D. 21, 2015): Mississippi does not recognize any cause of action against a voluntary non-profit trade association like TMA. . . . [T]he Such power rests solely with the FDA.” Donnatacci , 531 A.2d

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Doctors Fraud Licensing Compliance 52

Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

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FDA Governance 52

Drug & Device Law

APRIL 25, 2022

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures. Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. continue to be subject to Rule 407-based exclusion.

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FDA Governance 52

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. Polansky v. 3d 239 (Cal.

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

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

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FDA Fraud Governance Medicare 72

Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § 2015) (Gorsuch, J.). Plaintiffs’ Legal Committee , 531 U.S. Plaintiffs constantly try to evade Buckman.

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FDA Governance Fraud 72

Drug & Device Law

MARCH 16, 2022

As you must know by now, the pelvic mesh MDL court ruled that the FDA 510(k) regulatory clearance of pelvic mesh devices was irrelevant because such clearance was not probative of safety. But the plaintiff did not file her lawsuit until March of 2015. Arizona March 1, 2022) – focuses on the regulatory status of the device.

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FDA Governance Licensing 69

Drug & Device Law

DECEMBER 6, 2022

According to the FDA, nothing, and that’s why the court dismissed the putative class action in Beasley v. As it turns out, thanks to very specific language from both the FDA and Congress, neither could the presence of PHOs before 2018. Like with drugs, foods regulated by the FDA cannot be “adulterated.” Tootsie Roll Indus.

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Drug & Device Law

JULY 26, 2023

2018), holding (as discussed here ) that New Jersey multi-county mass-tort litigation will henceforth be governed exclusively by New Jersey law, no matter where the plaintiff resided. 2015 WL 5567578, at *6-7 (W.D.N.C. 22, 2015) (admitting §510(k) compliance in pelvic mesh case under North Carolina law). 3d 503, 523 (N.J.

Compliance 52

Compliance FDA Licensing Governance 52

Drug & Device Law

JANUARY 16, 2023

As we’ve also discussed previously , the FDA imposes tight restrictions about anything that a regulated entity proposes to say about off-label uses in the label. 49603, 49605-06 (FDA Aug. at *4 (“plaintiffs focus their appeal on the three Japanese studies not originally submitted to the FDA”). quoting 73 Fed. 22, 2008)).

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Drug & Device Law

AUGUST 25, 2023

As it became widely used off-label for morning sickness, the FDA considered, but did not require, pregnancy-related labeling. Litigation began over alleged birth defects in 2015 and whether the manufacturer should have added warnings about that issue. Over three, apparently. With the case reassigned to a new judge in the middle.

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FDA Governance 52

Drug & Device Law

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. The rulemaking process governing monographs was replaced with an administrative order process. Levine , 555 U.S. Plaintiffs Legal Committee , 531 U.S.

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FDA Governance Nurses 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

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FDA Licensing Hospitals Governance 59