Health Law Pulse

FEBRUARY 11, 2022

During a recent Q&A, a representative with the World Health Organization warned that the Omicron variant is not the last of its kind. Dr. Maria Van Kerkhove explained that the next variant is likely to be more transmissible and could be more deadly than any of the previous variants.

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Health Populi

JULY 28, 2020

In 2020, CES featured several hundred digital health exhibitors and a growing array of Internet of Things-connected devices adjacent to health and wellness, with representation from beyond “pure” wearable health tech ranging from FDA-cleared blood pressure watches from Omron to health insurer Humana in the exhibit hall.

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HIT Consultant

SEPTEMBER 2, 2022

Thus, the app is changing the way people perceive, learn, access and talk not only about menstrual health but also about reproductive health for women. In December 2021, the company received clearance from Food and Drug Administration (FDA) for its digital contraceptive device and the same is now being rolled out in the U.S.

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Bill of Health

FEBRUARY 27, 2024

Regulatory Process Ideally, a novel therapy will undergo a translational process through which efficacy is determined and the therapy is adapted for delivery in diverse health care settings.

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Healthcare IT Today

JULY 12, 2023

The World Health Organization (WHO) is now even expressing the importance of adopting digital health technologies to address key health system challenges and support equitable care and access. The primary drivers of these developments are outcomes, cost, and experiences.

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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. Today is Day 4 of sharing: we consider the letters “P” through “T,” and what I saw in the early coronavirus era. P is for pandemic.

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Exeed Regulatory Compliance

MARCH 5, 2020

Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. The World Health Organization (WHO) has stopped short of classifying the outbreak as a pandemic, but consistently encouraged affected countries to activate their national emergency response plans.

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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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SQA

OCTOBER 18, 2024

Participants were from regulatory medicine agencies in low-, middle-, and high-income countries; experts on and developers of screening technologies and other key stakeholders, including the World Health Organization (WHO), Interpol, UNICEF, and the United States Pharmacopeia (USP).

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SQA

AUGUST 1, 2024

The adoption of these mechanisms is recommended and encouraged by the World Health Organization (WHO) so that the population has faster access to health services and technologies. In addition, the ISPE Guide outlines the authority of State Boards of Pharmacy and their coordination of oversight with the FDA.

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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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SQA

JUNE 3, 2024

Now the Ministry of Health has published revised regulations in accordance with Annex M of the Drugs and Cosmetics Rules. Last year, the World Health Organization (WHO) issued an alert about cough syrups being contaminated with diethylene glycol and ethylene glycol, which are toxic to humans and can prove fatal.

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SQA

OCTOBER 18, 2023

At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. FDA ensures that broad-spectrum sunscreens protect against both Ultraviolet A (UVA) and Ultraviolet B (UVB) radiation and are safe and effective. FDA is developing a paper form as an alternate submission tool.

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Bill of Health

OCTOBER 31, 2024

Food and Drug Administration (FDA) is expected to propose new rulemaking on front-of-package labeling in 2024. The World Health Organization (WHO) has recommended FOP labeling as a cost-effective intervention to improve population-level dietary habits. Since 2009, the U.S. No standardized system exists but the U.S.

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Public Health FDA Governance Licensing 100

Bill of Health

JULY 14, 2023

Public Health Service’s (USPHS) Syphilis Study at Tuskegee , whose revelation to the public sparked today’s legal schema for regulating and protecting the research it funds (the “Common Rule”), as well as research done in anticipation of receiving FDA approval for marketing a new product. While the U.S.

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Bill of Health

MARCH 27, 2023

All of this might make sense in a world where COVID has gradually become less prevalent and less of threat. But, if that world exists, it is somewhere in another dimension.

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SQA

DECEMBER 16, 2022

The entry into force closes a long revision process, which has been driven jointly by PIC/S and the EMA GMP/GDP Inspectors Working Group (GMDP IWG) in close co-operation with the European Commission (EC) and the World Health Organization (WHO). United States Food and Drug Administration (FDA) – Regulations and guidance.

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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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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). These enhanced surveillance efforts and other innovative data sharing practices significantly enhance real-time data at the core of public health communications. Vaccine allocations.

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Health Populi

AUGUST 31, 2023

health citizens of the vaccine fast-tracked to address the worst effects of the coronavirus. “Misinformation” has taken on many names: infodemic ( coined by the World Health Organization in August 2020 ), fake news, conspiracy theories, and malinformation among the monikers.

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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

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. United States Food and Drug Administration (FDA) – Regulations and Guidances. PDA Technical Report No.

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SQA

OCTOBER 18, 2024

Participants were from regulatory medicine agencies in low-, middle-, and high-income countries; experts on and developers of screening technologies and other key stakeholders, including the World Health Organization (WHO), Interpol, UNICEF, and the United States Pharmacopeia (USP).

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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. FDA is developing a paper form as an alternate submission tool.

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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. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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SQA

JULY 8, 2022

Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers. World Health Organization (WHO). of devices worldwide have experienced this problem. WHO Pharmaceuticals Newsletter, No.

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Bill of Health

MARCH 5, 2025

Food and Drug Administrations (FDA) new proposed rule on a front-of-package nutrition label, called a Nutrition Info box. From 1941 to the 1970s, FDA recommended food labels be used only for food products designed for special diets to treat physical and pathological conditions. This is the driving motivation behind the U.S.

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US Department of Health and Human Services FDA Public Health World Health 130

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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Hall Render

JANUARY 31, 2025

’s Vanda Pharmaceuticals battling FDA on multiple fronts Howard University physician group taps insider to be next CEO Deadline approaching for DC’s health care exchange D.C. is Americas loneliest city. Can 1,000 robotic pets help?

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US Department of Health and Human Services Nursing Homes Nurses Medicaid 40

Hall Render

JANUARY 24, 2025

NATIONAL 2025 ushers new era in physician unions CMS faces renewed legal pressure on drug price negotiation program DOJ sues Walgreens for knowingly’ filling millions of prescriptions that lacked legit medical purposes Employer cost-cutting pushes tech companies to merge Expect more hospital mergers in 2025, with deals driven by distress and (..)

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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.

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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 27, 2022

Filing a citizen’s petition, Valisure shocked the FDA into an ill-advised recall by reporting that “tests found NDMA in ranitidine in excess of 3,000,000 ng [nanograms] per pill” – far above FDA’s 96 ng/day “daily limit.” The FDA recognized these results as bogus, “conclud[ing] that. . . 2022 WL 17480906, at *1.

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Drug & Device Law

APRIL 7, 2022

Christiana Care Health Servs., In short, as the FDA , every major medical organization, and even a manufacturer of ivermectin has concluded, there is no basis to think that ivermectin is an effective treatment for COVID-19. 3d 423, 435 (Del. Judges might not be doctors, but in the case of ivermectin the courts have gotten it right.

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