A New Era for Medical Device Regulation: Inside FDA’s QMSR Transition
Medical device regulation is an imperative yet cumbersome process that spans throughout a product’s lifecycle, from initial development and premarket approval and ending with post-market surveillance. Since 1978, the FDA has steadily improved U.S.-centered regulations governing medical device manufacturing to ensure companies remain compliant with an array of evolving safety […]
Two Florida Women Subject to Judge-Mandated C-Sections Raise New Concerns About Pregnant People’s Diminishing Right to Bodily Integrity
A recent ProPublica investigation revealed how two Florida women, Cherise Doyley and Brianna Bennet, were forced via a judge-ordered mandate to birth their children through C-sections, overriding their wishes for vaginal births and highlighting a new and concerning element to Florida’s fetal-personhood agenda. In September of 2024, during her twelfth […]
Cyber Warfare and the HIPAA Security Rule: Protecting Health Data in an Era of Geopolitical Conflict
Modern warfare has extended into the digital domain, where cyberattacks against private companies and critical infrastructure are increasingly used as tools in geopolitical conflict. The healthcare sector, which heavily relies on digital systems for storing sensitive patient information, is a particularly vulnerable target. This vulnerability, which can be increased during […]
Biosecurity Catching Up to the Modern Era: A Look Into S.3741
Biotechnology is a rapidly evolving field, touching almost all parts of the human experience. The field has become a stronghold in the United States due to increased investment and a new multi-disciplinary approach to the developing research. Though these innovations are important for the future of disease prevention and the […]
The Decline of Antibiotics and the Rise of Antimicrobial Resistance: Could the PASTEUR Act be the Solution?
The discovery of penicillin by Alexander Flemming in 1928, and the golden age of antibiotic development that followed, significantly decreased the global threat of bacterial infections. However, the evolution of countless pathogen strains to resist antibiotics coupled with the lack of funds for antibiotic development has resulted in an acceleration […]
