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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.

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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. Pro Tip: We are in a moment of transition.

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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.

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How clinical outcome assessments can help us understand the patient experience

Clarivate

More recently, the FDA has developed the Patient Focused Drug Development (PFDD) Guidance Series, which provides sponsors with guidance on how to collect and submit patient experience data in medical product development for regulatory decision making. All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

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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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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.

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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., “A massive inflection point in our device development journey” Acorai’s CEO and Co-Founder Filip Peters said, “We could not be more delighted with the decision from the FDA, and it constitutes a huge milestone for us as a company. .