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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COVID-19 Nurses FDA Licensing 103

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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FDA Compliance COVID-19 Public Health 52

SQA

OCTOBER 18, 2022

Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. PDA Technical Report No.

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US Department of Health and Human Services FDA COVID-19 Compliance 40

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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US Department of Health and Human Services FDA COVID-19 World Health 40

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. The addition of Annex 2, which describes the CPCA for N -nitrosamines.

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FDA Compliance Licensing World Health 40