Pharmaceutical and medical device manufacturers should not assume that recent staff cuts at the US Food and Drug Administration (FDA) mean the Agency will inspect less often and take fewer enforcement actions, according to a panel of experts who spoke at a Food and Drug Law Institute (FDLI) webinar on 01 MAY 2025.
The upcoming change to Quality Management System Regulation (QMSR) is similar to requirements of the Quality System (QS) Regulation under 21 CFR 820; however, not so similar that companies should think they have no work to do during the transition, US Food and Drug Administration (FDA) officials said at the 2025 MedCon conference in April 2025, sponsored by the AFDO/RAPS Healthcare Products Collaborative.
Blood proteins may predict speed of brain aging: Researchers have identified 13 blood proteins that predict brain aging speed, with eight (8) linked to faster aging and five to slower aging, according to a study in Nature Aging. The study used a machine-learning model to analyze brain scans and blood samples from more than 10,000 people, finding that the brain ages of participants differed from their chronological ages by about three years on average.
Study with mice shows potential of engineered T-cells to treat Celiac Disease: A cell therapy for Celiac Disease that involves engineering regulatory T-cells to activate in the presence of gluten reduced the immune response associated with the disorder, according to a study in Science Translational Medicine. The study demonstrated the potential of this therapy in human cell cultures and mouse models, and could lead to the first treatment for Celiac Disease beyond a gluten-free diet.
Challenges and advances in HIV treatments: It was recently announced that a seventh (7th) person had been “cured” of HIV using a stem-cell transplant, a method that is effective in patients with both HIV and cancer that require bone marrow transplants; however, unsuitable for widespread use due to potential complications. Current HIV research is concentrated on long-acting injectable treatments, vaccines and gene therapies aimed at controlling latent reservoirs of infected cells or targeting the CCR5 receptor that HIV uses to enter cells, with some approaches in early clinical trials.
A team of scientists at the National Institutes of Health (NIH) has developed an eye drop that successfully slowed vision loss in mice with an inherited eye disease.
United State (US) manufacturing has not been hollowed out, writes a Senior Research fellow at George Mason University. “Industrial production is higher than ever.”
Tampon-based test shows promise in detecting endometrial cancer: The Mayo Clinic and Exact Sciences have developed a tampon-based test to detect endometrial cancer by analyzing vaginal fluid for methylated DNA biomarkers. This noninvasive method offers a potential alternative to traditional endometrial sampling, reducing discomfort for patients.
Despite the uncertainty currently sweeping through the Food and Drug Administration (FDA), President Donald Trump’s pick to lead the U.S. regulator has passed a final vote of confidence from the Senate with little friction.
The Centers for Disease Control and Prevention (CDC) is reportedly rescinding $11.4 billion in funds to states, cities and organizations receiving grants for COVID-19 efforts.