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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. 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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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. appeared first on Pharma Marketing Network.

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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. Globalisation and supply chain complexity are a factor.

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UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma. Christophe Vaessen. For more information, please visit www.uromems.com.

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Diversity and inclusion in oncology clinical trials

Clarify Health

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. J National Comprehensive Cancer Network. To advance equity in clinical research, the U.S. 2019;17(11):1309-1316.

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The Top 3 Legal Considerations for Pediatric Digital Health Companies

Nixon Gwilt Law

Pediatric healthcare innovation companies—especially those in AR/VR/XR, Digital Therapeutics (“DTx”), Remote Monitoring, Virtual Care Management, Telehealth, and Telebehavioral health—need a deep understanding of the laws and regulations that govern this special market. The Family Educational Rights and Privacy Act (“FERPA”), is a U.S.

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Healthcare Watch July/August 2022

PM360

When asked about driving diversity in clinical trials, 31% of surveyed oncologists felt the best solution is to create a network of clinical trial sites in underserved communities. EPA Administrator Michael Regan said the agency will take more aggressive action against PFAS. Drug Approvals. FDA Update.