Makary reportedly on the way out at FDA, new guidance, and more
Multiple outlets reported that FDA Commissioner Marty Makary is being pushed out at FDA, though it is unclear how or when the departure will take place.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) proposes indefinite acceptance of CE-marked medical devices
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.
Makary announces one-day inspection pilot for low-risk facilities
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.
Pigs and grizzlies, not monkeys, hold clues to youthful human skin
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.
New paper urges caution as FDA plans to phase out animal testing in drug development
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.
Moderna hit with FDA refusal-to-file letter for mRNA flu shot, issues sharp rebuke of FDA’s rationale
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.
Inside the Most Common FDA Inspection Issues
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.
Patient survived 48 hours without lungs before transplant: The external, artificial-lung system could be used to treat other people who are critically unwell and awaiting transplants.
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 find chronic stress you can see, using a CT scan
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.”
Grey hairs grow when your body shuts down cancer-prone cells, study suggests: Rather than a depressing sign of ageing, our grey hairs are battle scars in our body’s war against cancer
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.