Exeed Regulatory Compliance

MARCH 5, 2020

A novel coronavirus, now called SARS-CoV-19, was first detected in the Hubei province of China in early December 2019. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb.

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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

DECEMBER 16, 2022

19 Medical Rehabilitation Equipment. Medicine shortages and reduced availability of medicine represent an increasing issue across the European Union (EU) and the globe, which has been amplified by the COVID-19 pandemic. United States Food and Drug Administration (FDA) – Regulations and guidance. CMDE Announcement No.

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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

AUGUST 8, 2023

Experience with large-scale events such as Hurricane Maria and the COVID-19 pandemic, and more recent geopolitical events, have cast a wider lens on global supply chain and distribution vulnerabilities. The model provides expanded guidance that reflects new insight and best practices that have emerged in the past several years.

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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). Unlike COVID-19, monkeypox infection is not usually fatal, but its symptoms can be painful and disabling. As seen repeatedly during the COVID-19 pandemic, U.S.

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Health Populi

AUGUST 31, 2023

The phenomenon of medical mis-information accelerated during the COVID-19 pandemic, normalizing weird anti-science and culminating in the rejection among many U.S. health citizens of the vaccine fast-tracked to address the worst effects of the coronavirus. KFF fielded the study in May and June 2023, finding that most U.S.

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SQA

OCTOBER 18, 2022

Health Canada. Counterfeit COVID-19 Antigen Rapid Test Kits Found in Ontario, 05 August 2022. Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. Health Advance Inc. PDA Technical Report No.

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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

APRIL 7, 2022

Over the past seven months, we reported ( here , here , here , here , here , and here ) on cases in which relatives of individuals sick with COVID-19 sued to force hospitals to administer ivermectin to their loved ones. Christiana Care Health Servs., Jones , 637 S.W.3d 3d 202, 207 (Tex. 3d 423, 435 (Del.

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