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How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

Nixon Gwilt Law

That said, the flurry of regulatory policymaking and legislation, congressional hearings and inquiries, and industry stakeholder organization around the development and deployment of healthcare AI portends major developments in the coming years. HIPAA is the pantheon of healthcare data privacy regulation in the U.S. HIPAA What is it?

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Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. The post Why Is FDA Issuing Fewer Marketing Violation Letters?

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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. Lack of proper training can lead to errors, omissions, or intentional data manipulation, which can compromise data.

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How clinical outcome assessments can help us understand the patient experience

Clarivate

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. We developed or explored over 100 COAs and achieved ethical approval in multiple countries including the U.S.,

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2022 Trends and Opportunities for Healthcare and Life Sciences Businesses and Investors

Nixon Gwilt Law

What can Healthcare and Life Sciences businesses and investors anticipate for the healthcare industry in 2022? We asked our team five direct questions about innovations in healthcare, life sciences, and digital health in the coming year: What healthcare trends or opportunities are you most excited about?

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Acorai receives Breakthrough Device Designation for their Non-Invasive Intracardiac Pressure Monitor

Legacy MEDSearch

The device is intended as a companion test for qualified healthcare professionals (HCPs). Acorai has ethics approval in 5 countries, including the U.S., Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. The full analysis of this study is currently being prepared for publication.

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Cancer: Progress but a long way to go

World of DTC Marketing

But it’s’ still the leading cause of cancer deaths. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease. The Food and Drug Administration approved them, an analysis JAMA Internal Medicine found.