Natalia Mazina

AUGUST 16, 2022

Recently – on July 6, 2022 – the FDA amended the Emergency Use Authorization (EUA) for Paxlovid, an orally-administered COVID-19 therapeutic drug. Recently – on July 6, 2022 – the FDA amended the Emergency Use Authorization (EUA) for Paxlovid, an orally-administered COVID-19 therapeutic drug.

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COVID-19 Informed Consent FDA Licensing 98

SQA

MAY 17, 2022

The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements. United States Food and Drug Administration (FDA) – Regulations and Guidances. Additional details for each annex are provided within the content section of the document.

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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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Healthcare Law Blog

AUGUST 9, 2023

8] The court in Members of the Medical Licensing Board of Indiana, et al. The now-active provisions include a prohibition on abortions after 12 weeks of pregnancy (with limited exceptions), 72-hour informed consent requirements, pre-abortion gestational age verification, and reporting requirements for abortions after 12 weeks. [21]

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Licensing Informed Consent Nurses FDA 52

Hall Render

FEBRUARY 10, 2023

over Claims Practices Where things stand in Central California 1 month after a community hospital’s closure California hospital names Kelly Linden CEO Upcoming California health bills to watch, including a conversation with Rep. Blue Shield of California is counting on it. million to UMass Memorial Health Care for COVID-19 costs Four Mass.

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

Drug & Device Law

FEBRUARY 29, 2024

Not to mention, it is a powerful defense for our clients in product liability matters because it can foreclose liability and plaintiffs’ use of tort lawsuits (invariably creatures of state law origin) to impose requirements on medical devices or pharmaceuticals that the federal FDA did not. What could be better than preemption?

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COVID-19 Informed Consent FDA Governance 59

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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