Healthcare IT Today

JUNE 13, 2023

The previous articles in this series laid out some of the issues in health care affecting testing , and the value of data. This article looks at some specific problems and solutions. Virax Biolabs uses data from the World Health Organization and others to develop tests quickly.

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SQA

FEBRUARY 26, 2024

” If the product is prohibited in Brazil, a notice of infraction is drawn up for smuggling of goods (Article 334 A, item II, of the Criminal Code), which is then sent to the Public Prosecutor’s Office for criminal investigation. After this period, the product is characterized as an “abandoned commodity.”

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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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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. It rapidly caused a widespread epidemic in China and has spread to over 50 countries outside of China with more than 90,000 confirmed cases and 3000 deaths at the time of this blog article.

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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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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. The application/notification must be submitted via the EUDAMED database (Article 69 IVDR).

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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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