Healthcare IT Today

JUNE 13, 2023

Virax Biolabs uses data from the World Health Organization and others to develop tests quickly. Esquivel says, “ixlayer partners with CLIA-accredited laboratories and performs a rigorous vetting process of their validations protocols and operational capabilities from the licensing perspective on a state-by-state basis.

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COVID-19 Nurses FDA Licensing 105

Healthcare IT News - Telehealth

MAY 30, 2023

This also happens to coincide with the World Health Organization declaring an end to the COVID-19 global health emergency. What can be expected in healthcare and health IT now that the PHE has ended, and what does this mean for the future of telehealth? The fact is nothing that dramatic happened on the day the PHE ended.

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Telemedicine COVID-19 Governance Medicare 190

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

SQA

DECEMBER 16, 2022

Since health authorities have not yet published guidelines for a comprehensive control strategy specific to microbiological topics for ATMPs, it is up to the individual ATMP sponsor or license holder to apply these compendial references properly. United States Food and Drug Administration (FDA) – Regulations and guidance.

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FDA Compliance COVID-19 Licensing 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.

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FDA Compliance Licensing World Health 40

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 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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FDA Compliance COVID-19 Public Health 52