SQA

AUGUST 2, 2021

ISO 13688:2013, Protective clothing – General requirements. ISO 13688:2013/AMD 1:2021, Protective clothing — General requirements — Amendment 1. ISO/TS 16976-8:2013, Respiratory protective devices – Human factors – Part 8: Ergonomic factors. United States Food and Drug Administration (FDA) – Guidances for Drugs and Biologics.

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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. 439, 448 (2013). [15] In this post, I argue that young people should have the opportunity to consent to vaccines. Sugarman, 566 F.2d 2d 817, 825 (2d Cir. Rodriguez, 411 U.S.

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COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Healthcare IT Today

JUNE 17, 2024

Founded in 2013 by Dr. Elina Berglund Scherwitzl and Dr. Raoul Scherwitzl, Natural Cycles developed the first direct-to-consumer contraceptive app that has been used by more than three million users worldwide. Lauxera is a healthcare specialist investor working to promote the growth of European Healthtech companies.

FDA 78

FDA Governance 78

SQA

JUNE 10, 2021

Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021. The Government of Canada’s number one priority is to protect the health of Canadians. FDA plant inspection and pay $50 million in fines and forfeiture.

COVID-19 52

COVID-19 FDA COVID-19 Vaccine 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

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

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

JANUARY 30, 2023

472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. 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. Kent , 552 U.S.

FDA 72

FDA Fraud Governance Medicare 72

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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FDA Compliance Governance 59

Drug & Device Law

NOVEMBER 28, 2022

2013) (Painter); McClellan v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). 2019) (Augustine); In re Mirena IUD Levonorgestrel-Related Products Liability Litigation (No. II) , 341 F. 3d 213, 222-23, 229-32 (S.D.N.Y. 2018) (Etminan); Gerke v. Travelers Casualty Insurance Co. ,

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

OCTOBER 7, 2022

One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our Contraceptive devices without a pharmacologic action have not avoided litigation. Our posts go back for more than six years.) risks and benefits) for all patients.

FDA 59

FDA Fraud Doctors Public Health 59

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.

FDA 52

FDA Governance 52

Drug & Device Law

MARCH 25, 2022

Just as the previous Fosamax MDL judge had back in 2013, the current Fosamax MDL judge found all of the plaintiffs’ claims (only warning claims appear now to be at issue) preempted – only this time as a matter of law under Albrecht. At the FDA’s suggestion, the manufacturer withdrew that supplement, but kept trying. femur fractures.

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FDA Governance 52

Drug & Device Law

MARCH 3, 2022

have dockets heavy on administrative cases and other cases involving the functioning of the federal government and light on product liability cases. 12-cv-734, 2013 WL 1739580 (D.D.C. March 21, 2013). With more than eight years on the federal bench, that is not many decisions. Part of that may be that the D.D.C. Even the D.C.

FDA 59

FDA Fraud Governance 59

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. § 2013), aff’d, 784 F.3d Plaintiffs’ Legal Committee , 531 U.S. Plaintiffs constantly try to evade Buckman.

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FDA Governance Fraud 72