Bill of Health

OCTOBER 31, 2024

by Alice Bryk Silveira The alarming rise in diabetes and obesity rates in the United States has placed significant strain on health care systems and poses a serious public health threat. Despite international momentum and calls from public health experts, the United States remains behind. Since 2009, the U.S.

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Health Populi

AUGUST 12, 2020

The “P” word was uttered by the Secretary General of the World Health Organization on March 11, confirming that the coronavirus was, technically, a pandemic. The general theme here is that the pandemic is a global phenomenon, and that we humans are very small actors in a very big public health crisis.

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SQA

DECEMBER 16, 2022

It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. United States Food and Drug Administration (FDA) – Regulations and guidance. Computer Software Assurance for Production and Quality System Software, 13 September 2022.

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Bill of Health

MARCH 27, 2023

Bard The White House is preparing to shut down their COVID Task Force this May, in conjunction with ending the public health emergency — the latest in a series of astounding and shortsighted decisions that put individual Americans at as great a risk from serious harm as a result of catching COVID-19 as at any stage in the pandemic.

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SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

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SQA

FEBRUARY 15, 2023

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

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SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products.

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Bill of Health

AUGUST 8, 2022

On August 4, 2022, Health and Human Services (HHS) Secretary Xavier Becerra declared monkeypox a national public health emergency (PHE). Absent considerable public health interventions, considerably greater numbers of U.S. Monkeypox is America’s newest emergency—and not a moment too soon. Justifying a national PHE.

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SQA

AUGUST 8, 2023

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

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Health Populi

AUGUST 31, 2023

G” through her public health-informed broadcasts in the Miami media market during the pandemic. health citizens of the vaccine fast-tracked to address the worst effects of the coronavirus. Health Populi’s Hot Points: U.S. Geeta took on the persona of “Dr.

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Health Populi

SEPTEMBER 8, 2021

The Pew Trusts recently discussed prospects for the FDA to regulate AI in health care. Building a nutrition label for health equity – learning from MITRE . Questions about the ethics and governance of AI in health are being posed globally.

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SQA

OCTOBER 18, 2022

The UK sees the plans as an opportunity to introduce new regulations after Brexit in order to strengthen the public health sector. Policymakers, regulators, and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus.

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SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

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Drug & Device Law

MAY 11, 2023

A perusal of amicus briefs drew more than a few “they should know what they are talking about here” responses to groups of food and drug law scholars (as opposed to DDL bloggers), former FDA commissioners, former FDA officials, and former DOJ officials, among others. The appellate brief from FDA bears that out well.

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Drug & Device Law

DECEMBER 28, 2023

For another, the drug at issue has been used very widely for many decades and it is on the World Health Organization’s List of Essential Medicines. That FDA does not believe a true association requiring a warning exists is also obvious. The facts and posture are fairly simple. 2023 WL 8711617, *2.

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