Regulatory Affairs, SaMD & Digital Health Expert
I like to write about people, the places they live and the things with which they choose to surround themselves. Here are some of my favorite pieces that made it into Article.
Vinay Prasad’s Departure from the FDA: What You Need to Know In a significant shakeup, Vinay Prasad, a prominent official at the Food and Drug Administration (FDA), is set to leave the agency for the second time at the end of April. Prasad’s tenure has been filled with controversy, particularly within the Center for Biological …
Key Takeaways: Prime Medicine is seeking FDA approval for a novel gene-editing treatment. The treatment utilizes prime editing, a CRISPR-based tool introduced in 2019. It aims to help patients with chronic granulomatous disease (CGD) by correcting DNA defects. The FDA’s response to this application will be closely monitored amid growing scrutiny on gene therapies. This …
Building Bridges for Kids with Rare Diseases: A New Hope Every parent pictures a bright, healthy future for their child. For me, that dream felt shattered when my son Wheeler was just four weeks old. He was diagnosed with CLN3 juvenile Batten disease, a rare genetic condition that progressively robs children of their vision, memory, …
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 …