Regulatory Affairs, SaMD & Digital Health Expert
Understanding Hunter Syndrome: A Personal Journey and Recent Developments Megan Selser’s life changed dramatically two years ago. She was at home, cradling her 7-week-old son Ben, when she received the heartbreaking news that he had mucopolysaccharidosis type 2 (MPS II), also known as Hunter Syndrome. This rare genetic disorder can silently strip away a child’s …
Key Takeaways The Trump administration aims to lower challenges for AI developers in health care. Harrison.ai has proposed a plan for faster approval of AI products for radiologists. If approved, this could mean less oversight for some potentially risky AI tools. The FDA has a 180-day window to respond to Harrison.ai’s request. A former executive …
The Rise of Nicotine: A New Health and Wellness Trend In recent years, nicotine has been getting quite a makeover. It’s not just the bad-boy image associated with smoking; now biohackers, athletes, and even popular podcasters are praising it for its potential cognitive benefits. Stanford neuroscientist Andrew Huberman calls it a tool that “sharpens the …
Navigating Pain Medication Shortages: Who Gets Help? When pain medication is in short supply, tough choices emerge. Imagine a teenager in intense pain from a crushed leg competing for the same medication as an 80-year-old facing terminal cancer. This dilemma highlights a growing issue in American healthcare: the frequent shortages of essential drugs, especially intravenous …
FDA Rejects Bitopertin Treatment for Rare Blood Disorder Key Takeaways: The FDA has turned down bitopertin, a drug meant for a rare blood disorder called porphyria. This rejection is notable as it was the first drug evaluated under a new fast-track program by the FDA. The decision has caused a significant drop in Disc Medicine’s …
Key Takeaways The FDA has declined to review Moderna’s application for a new flu vaccine, raising questions about its relationship with drug companies. Moderna publicly shared the rejection letter and expressed frustration regarding the impact on innovative medicine development. The core issue revolves around what existing flu vaccine Moderna should have used as a comparison …
Key Takeaways The Department of Health and Human Services (HHS) is investigating Hims & Hers for potential federal law violations. The investigation follows the FDA’s announcement to tackle the marketing of unapproved, compounded weight loss drugs. The FDA aims to restrict certain active ingredients used in these compounded medications to protect consumer safety. What’s Happening …
Key Takeaways Trump administration officials blocked an FDA effort to expedite approval for a psilocybin treatment aimed at severe depression. The decision points to potential disagreements within the administration regarding health policies. Only one treatment, Compass Pathways’ psilocybin, was vetoed from the FDA’s list of prioritized medicines. What Happened? In an interesting turn of events, …
Key Takeaways Richard Pazdur, a former FDA regulator, raised concerns about diminishing boundaries between political influence and drug review processes. He highlighted a lack of transparency in a new voucher program that expedites drug reviews based on political decisions. Pazdur emphasized the troubling dismantling of 25 years of progress in drug regulation during his talk …
FDA Pauses Gene Therapy Trials After Child Develops Brain Tumor The FDA has recently paused trials for two experimental gene therapies developed by Regenxbio. This decision came after a concerning incident where a child participating in the trial developed a brain tumor. The therapies in question aim to address mucopolysaccharidosis type I and type II, …