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The FDA’s Unique Device Identification (UDI) requirement, implemented on September 23, 2013, celebrated its 10th anniversary in 2023. The UDI program has come a long way from its inception, evolving into a comprehensive framework that uniquely identifies and catalogs over 4 million medical devices in the Global Unique Device Identification Database (GUDID). This milestone has paved the way for advancements in supply chain operations, hospital management, patient safety, and clinical research.

The article reveals that Danish drugmaker Novo Nordisk has paid at least $25.8 million to U.S. medical professionals over a decade to promote its weight-loss drugs, specifically Wegovy and Saxenda. The company aims to position itself as the world’s leading weight-loss company, targeting the global obesity market, with a focus on the lucrative U.S. market where over two-thirds of adults are overweight or obese.

Summary: Pharmaceutical company Moderna is reportedly actively monitoring and policing online content related to COVID-19 vaccines through its disinformation department. Investigative journalists reveal that Moderna’s internal documents suggest a comprehensive effort to monitor social media, news websites, and government agencies to address vaccine hesitancy by identifying and shutting down what it deems as “misinformation.” The monitoring team includes former law enforcement, FBI, and Secret Service analysts, as well as pharma-funded NGOs.

Summary: The U.S. Food and Drug Administration (FDA) has issued a safety communication, notifying consumers, healthcare providers, and facilities about the ongoing evaluation of plastic syringes manufactured in China. The FDA is concerned about potential device failures, such as leaks, breakage, and other issues, affecting the quality and performance of these syringes. The issue, as of now, does not include glass syringes, pre-filled syringes, or those used for oral or topical purposes.

The agency received over 270 reports of thermal problems associated with these devices in the past three months, indicating a significant increase compared to the previous three years. Some of these devices were replacements for Dream Station 1 machines, which were recalled due to health risks linked to soundproofing foam. The FDA suspects the issue may be related to electrical or mechanical malfunctions causing overheating in specific situations.

Summary: In a recent article, Klaus Steger explores the potential dangers associated with the next generation of RNA-based vaccines containing self-amplifying RNA (saRNA). While saRNA replicates itself, offering the promise of increased antigen production with just one shot, Steger raises concerns about its genetic modification and the implications for our immune system.

Houston Methodist, the first U.S. hospital to mandate COVID-19 vaccines for employees, is dropping the requirement after a Texas law outlawed such mandates in the private sector. The hospital communicated the change in an internal email, stating that, effective December 1, employees will no longer be required to get vaccinated as a condition of employment. The Texas Legislature passed a law in a special session, prohibiting private employers from enforcing COVID-19 vaccine mandates.

March 25, 2014 by Stewart EisenhartA new report by the US Food and Drug Administration shows a 97% increase in recalls of medical devices between fiscal years 2003 and 2012 due to stepped up public safety efforts by both regulators and industry. The agency attributes its findings to improved incident reporting primarily among manufacturers of radiological devices and by firms previously cited for 21 CFR Part 806 observations.

Summary: A recent investigation by The BMJ reveals that Pfizer did not inform pregnant women participating in its respiratory syncytial virus (RSV) vaccine clinical trial about the safety concerns arising from a similar vaccine trial by GlaxoSmithKline (GSK). The GSK trial was halted due to a potential risk of preterm births leading to neonatal deaths. Despite being aware of this safety signal, Pfizer continued enrolling women in its trial without fully disclosing the risks.

President Biden is addressing widespread drug shortages by unveiling a plan to boost domestic pharmaceutical manufacturing, leveraging the Defense Production Act to increase essential medicine production in the U.S. The move comes as the number of drug shortages reaches a decade-high, with U.S. manufacturers heavily relying on overseas suppliers. Biden’s plan includes empowering the Health and Human Services Department to invest in non-pandemic-related medical products, such as insulin, morphine, vaccines, and ventilators.