The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is requesting feedback on a proposal to allow EU CE-marked medical devices sold in Great Britain to be recognized and sold indefinitely. This measure aims to ensure a continuous and uninterrupted supply of these devices.
Marty Makary, the Commissioner of the U.S. Food and Drug Administration (FDA), announced a new pilot program promising one-day inspections for low-risk facilities at the end of May 2026.
Research with pigs and grizzly bears showed that key skin structures called rete ridges, which help keep human skin strong and elastic, form after birth rather than during fetal development. The study, published in Nature, identified bone morphogenetic protein signaling as a key pathway and provides a concrete molecular target for therapies for wound healing, scar repair and age-related skin thinning.
FDA’s animal testing phaseout needs caution, experts say: Biomedical research with animals remains essential for preclinical safety testing, and rapidly replacing animal studies with unvalidated alternatives could increase the risk of unsafe or ineffective drugs reaching patients, legal expert Sara Gerke and colleagues wrote in Trends in Biotechnology. The Authors recommend maintaining animal testing alongside alternatives until enough data proves equivalence, and they propose measures like premarket reviews or independent certification to ensure the safety and efficacy of new methods.
During the first year of the Trump administration, signs of an anti-mRNA slant within the FDA and the Department of Health and Human Services (HHS) became more and more evident. Now, with a refusal-to-file (RTF) letter issued to Moderna over the company’s next-gen flu shot, the situation has been brought into a much clearer focus.
Despite two (2) decades of consistent FDA Warning Letter patterns, medical device companies continue making the same compliance mistakes with CAPAs, Design Controls, and complaints accounting for over one-third (1/3) of all citations.
A study published in Med examines the case of a 33-year-old man who was kept alive for 48 hours without lungs by connecting him to an external artificial-lung system that maintained normal blood flow through the heart until a double lung transplant could be performed. The system was originally developed to support critically ill COVID-19 patients and could offer a temporary lifeline for other critically ill patients awaiting transplant. There have been no signs of organ rejection or impaired lung function in the patient nearly three (3) years later.
Researchers said they have uncovered a novel sign of chronic stress and its damaging effects on the body by using an artificial intelligence algorithm to analyze common CT scans for what they describe as a “biological barometer.”
Greying hair might be a sign of anti-cancer defense: A study in Nature Cell Biology revealed that greying hair might be a byproduct of the body’s defense against cancer. Working with mice, researchers found that pigment-producing cells shut down when their DNA experiences double-strand breaks, preventing the spread of mutations. Over time, this leads to fewer pigment cells and grey hair.
MDR (the European Union [EU] Medical Device Regulation), MDSAP (the Medical Device Single Audit Program), and FDA Inspections demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market access.