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Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

Bill of Health

It allows third parties to use patented material for purposes reasonably related to the development and submission of information to regulatory authorities such as the FDA. However, the act of submitting an application to the FDA based on such research (e.g., Duke University, 307 F.3d 3d 1351 (Fed.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – June

SQA

On 09 May 2022, NMPA released the draft of the revised Regulations for Implementation of the Drug Administration Law (hereafter referred to as the Regulations ) for public comments. The Regulations were first issued with immediate effect in 2002 and were later revised in 2016.

FDA 91
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FDA Oversight of AI Software Developed by Health Care Providers

Health Law Advisor

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98
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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. PCPC’s current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act of 2022.

FDA 40
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Out of the Shadows: Menopause and the Law

Bill of Health

by Rupa Palanki In May 2024, a bipartisan group of female senators introduced the Advancing Menopause Care and Mid-Life Women’s Health Act. If enacted, it would be the most comprehensive federal effort to improve health care related to menopause. FDA Reconsideration of the Boxed Warning on Low-Dose Estrogen The U.S.

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SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States Food and Drug Administration (FDA) – Guidances for Drugs and Biologics.

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