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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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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. There is growing awareness of the importance of implementing robust data governance frameworks and compliance programmes to ensure the integrity of data.

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Navigating the World of Medical Device Equipment Sales: Tips for Success

Rep-Lite

While the rewards can be significant, carving a successful path in this field requires a unique blend of technical knowledge, interpersonal skills, and a commitment to ethical practices. Regulatory Awareness: Staying informed of regulatory requirements governing medical devices is crucial.

Medical 52
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How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

Nixon Gwilt Law

Its three separate Rules (Security, Privacy, and Breach) impose a variety of security controls, documentation, governance, and notice requirements on custodians of protected health information (PHI). The HTI-1 Final Rule is an AI disclosure and governance rule published by the US Department of Health and Human Services (HHS).

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Canadian and US developers to trial psychedelic medicines in UK

European Pharmaceutical Review

The UK’s regulatory pathway and fast-track drug approval process enables companies to fast-track their ethics applications and combine their reviews. The regulators are the Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) respectively.

Medicine 100
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The Future of Medical Sales Careers: Trends, Challenges, and Opportunities

Rep-Lite

Regulatory Changes and Compliance Challenges Navigating the intricacies of healthcare sales involves staying attuned to the ever-evolving regulatory framework that governs the industry. Don’t get it wrong, these are all aimed at ensuring patient safety, transparency, and ethical standards.

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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. His efforts included bridging and coordinating activities with key government entities.