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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. A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions or survives.

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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Lack of proper training can lead to errors, omissions, or intentional data manipulation, which can compromise data. What is an effective solution?

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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? appeared first on Pharma Marketing Network.

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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. Effective: Ensures that DSIs achieve their intended outcomes, improving clinical decision-making and patient care.

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Adding these developments with the addition of connected IoT devices, supply chain restructuring and consideration for our code of ethics will give us a glimpse at how pharmaceutical production will look in future. Internet] US Food and Drug Administration (FDA). Tuijin Jishu / Propuls. 2023; 44(3):1384-1392. cited 2023Dec].

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

Legacy MEDSearch

The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure. Acorai has ethics approval in 5 countries, including the U.S., “Andrew J.

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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. Additionally, Brexit has introduced uncertainty and disruption, further impacting the sector.