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FDA FHIR Pilot Automates Adverse Events Reporting and Validation with Cedars-Sinai and the VA Through eHealth Exchange

Healthcare IT Today

The following is a guest article by Jay Nakashima, President at eHealth Exchange An FDA project aims to make it as easy as possible for clinicians to report adverse drug events and share important clinical data with public health agencies to investigate the event.

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Weekly Roundup – September 21, 2024

Healthcare IT Today

Read more… FDA FHIR Pilot Automates Adverse Events Reporting and Validation. Jay Nakashima at eHealth Exchange detailed how California’s Cedars-Sinai used FHIR to send adverse events related to COVID-19 vaccines to the FDA – a process that replaced manual data entry and faxing.

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Labcorp Offers Observed Collections of COVID-19 PCR testing in Over 500 Patient Service Centers

HIT Consultant

Labcorp (NYSE: LH) is now offering observed self-collection for COVID-19 PCR testing in more than 500 of its patient service centers (PSCs) nationwide for people without symptoms or known exposure. Food and Drug Administration (FDA), and worked with companies to develop COVID-19 vaccines and therapies.

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The Healthcare and Macro-Economic Impacts of Living with Endemic COVID – Listening to Fitch

Health Populi

Translation: watch out for winter and flu season, especially if people don’t re-mask and take care to protect themselves and others — particularly important in geographies where more folks have opted out of getting vaccinated. We also expect innovation to come out of pharma and biotech labs, and who will pay for new-new therapies?

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Future Trends and Regulatory Challenges in Pharma

Dot Compliance

The race to develop a COVID-19 vaccine highlighted the power of artificial intelligence (AI) and machine learning (ML) as Johnson & Johnson, Moderna and Pfizer employed these technologies to swiftly get their vaccines to market. The next evolution is for companies to implement Industry 4.0 References. References.

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SQA Regulatory Surveillance Summary 2 | Monthly Update 2021

SQA

United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency, January 2021.

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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

The report summarizes the main activities of the year, such as general and normative publications, regulatory projects, community participation events, and innovations implemented. Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021.