The European Commission in the beginning of May 2026 published an implementing regulation that outlines uniform quality management and procedural requirements for conformity assessment activities conducted by notified bodies under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
In the latest update to COVID and vaccine-related discourse bubbling up at the FDA, Agency officials have recently blocked the publication of several safety studies conducted on COVID and shingles vaccines, The New York Times reported in mid-May 2026.
Looking to clarify its expectations for manufacturer responses following inspections, the FDA earlier this year (in 2026) unveiled, for the first time, draft Guidance on best practices for the industry when replying to the receipt of a Form FDA-483, Inspectional Observations.
U.S. Food and Drug Administration (FDA) Commissioner Marty Makary said the Agency should apply the same urgency as it did to approve the first treatments for HIV/AIDS in the 1990s to new drugs and medical devices, including those for Alzheimer’s disease, Type 1 diabetes, and cancer.
Changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are in the pipeline; however, a speaker at a recent meeting (in Columbus, Ohio) told attendees not to change their priorities based on proposed legislation.
The European Association of Medical devices Notified Bodies (Team-NB) is concerned that some of the targeted revisions planned for the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to ease post-market surveillance requirements may compromise patient safety.
Rabbit research shows contact lens that senses and treats glaucoma: A smart contact lens tested with rabbits and cow eyes tracked eye pressure and released glaucoma medication when needed, using a design that responds to changes in eye shape, according to a study in Science Translational Medicine. It worked in both normal and high-pressure eyes and could improve treatment by giving more accurate, continuous measurements while reducing the need for daily eye drops.
Budget plan proposes cuts to science funding: The Trump administration’s 2027 budget proposal includes significant cuts to US science agencies, with the National Science Foundation (NSF) and Environmental Protection Agency (EPA) facing reductions of over 50%. The proposal also suggests eliminating funding for certain National Institutes of Health (NIH) and National Oceanic and Atmospheric Administration’s (NOAA) research offices. The proposal would also prohibit the spending of “federal funds for expensive subscriptions to academic journals and prohibitively high publishing costs unless required by Federal statute or approved in advance by a Federal Agency.” The budget would increase military spending and prioritize research in quantum information and artificial intelligence (AI).
While the opioid epidemic is one of the most urgent public health emergencies facing the U.S., new therapeutic approaches for treating the underlying substance use disorder have lagged far behind. Scientists have now used an Artificial Intelligence (AI) program to design a compound that reduced fentanyl use in addicted rats, which could one day serve as a new tool to help patients recover from opioid abuse.