Blog Articles

The U.S. Food and Drug Administration (FDA) has uncovered new manufacturing issues at Eli Lilly’s plant in Branchburg, New Jersey, as per government records obtained by Reuters. The FDA inspection in July revealed eight deficiencies, including problems in tracking manufacturing processes, quality controls, equipment calibration, and facility maintenance. The inspection report, obtained through a Freedom of Information Act request, has some redactions.

Emergency medicine physicians Jesse M. Pines, MD, MBA, MSCE, and Amer Aldeen, MD, address the rising issue of burnout within their specialty. According to a recent survey, nearly two-thirds of emergency medicine physicians report burnout, the highest among all specialties. The authors present four unique strategies to address this challenge: Addressing ED Inefficiencies: Hospitals should focus on fixing Emergency Departments (EDs), addressing issues like boarding, insufficient capacity, and inefficient processes.

Dr. Theresa Bell, an MD in Endocrinology, raises concerns about the off-label use of Ozempic, a diabetes drug, for weight loss due to reported serious side effects. Instead, she suggests a safe alternative—probiotic strains that work through the same hormone, GLP-1, without the drawbacks of Ozempic. Dr. Bell explains that Ozempic slows down food leaving the stomach, promoting fullness and reduced calorie intake. However, users have reported severe side effects. Probiotics, according to Dr.

This number, excluding emergency use authorizations (EUAs), marks the highest level of activity in the over 40-year history of the CDRH. Over the past 15 years, there has been a consistent increase in the annual authorization of new devices by the FDA. Notably, in 2018, before the pandemic, annual authorizations peaked at 106. The year 2020 saw a record of 132 authorizations, including the approval of the first point-of-care and home-use tests for COVID-19.

This request comes in the wake of Philips’ recall of over 15 million respiratory devices that has been ongoing for two-and-a-half years. The GAO spokesperson mentioned that the office aims to start the investigation soon, but details about the timeline were not provided. Senators Durbin and Blumenthal had expressed concerns about the FDA’s handling of medical device recalls, particularly citing missed opportunities in mitigating harm to patients affected by the Philips recall.

Summary: A recent review published in Vaccine highlights potential adverse effects of non-live vaccines, including influenza, COVID-19, hepatitis B, and DTaP, on all-cause mortality and susceptibility to related infections. Live vaccines, like oral polio and BCG, demonstrate beneficial effects on the innate immune system, while non-live vaccines may weaken it. The study, based on extensive work by Danish researchers Dr.

A recent study published in The Lancet Microbe has shed light on the prevalence of laboratory-related infections (LAIs) and accidental pathogen escapes from facilities over the past two decades. The findings, based on analysis of 94 reports between 2000 and 2021, indicate a significant number of cases, with 309 LAIs and 16 incidents of accidental pathogen escape.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled its roadmap for 2024, outlining plans for future medical device and in vitro diagnostic (IVD) regulations. The agency aims to implement 11 core regulations, including the introduction of implant cards for patient device tracking, unique device identifiers (UDI) for easier product tracking, and changes in the classification of certain devices to align with international standards.

The health technology sector, which experienced a rapid digital transformation during the COVID-19 pandemic, faces evolving trends in 2024. While funding has slowed compared to the 2021 boom, interest remains high, particularly in artificial intelligence (AI). Consolidation is expected, with digital health companies being potential acquisition targets. Evaluating the effectiveness of digital health solutions becomes crucial as some startups mature.

The FDA anticipates extended shortages of automated external defibrillators (AEDs), specifically wearable and non-wearable types, now expected to persist until summer 2024. This update follows an increase in demand and challenges in the supply chain, including shortages or discontinuations of components such as batteries, pad electrodes, and adapters. Semiconductor chip shortages globally also contribute to the ongoing AED scarcity.