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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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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). Tuijin Jishu / Propuls. 2023; 44(3):1384-1392. cited 2023Dec]. Machine Learning in Medicine.

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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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Strengthening and transforming the pharmaceutical supply chain

European Pharmaceutical Review

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Some countries have blocked parallel trade to prevent supplies from depleting.

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

Nixon Gwilt Law

Appropriate: Guarantees that DSIs are suitable for the contexts and populations in which they are used, adhering to relevant clinical and ethical standards. In a recent blog post, the FTC illustrated how an AI company’s TOUs and PPs might lead to enforcement action.

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

Legacy MEDSearch

Acorai has ethics approval in 5 countries, including the U.S., It would be expected that with accuracies similar to invasive alternatives, system-wide use would almost certainly lead to resource savings while simultaneously improving outcomes for patients with heart failure.”