Month: April 2025

FDA urged to collaborate with EMA (European Medicines Agency) to accelerate rare disease drug approvals: A report by the National Academies of Sciences, Engineering and Medicine recommends that the FDA enhance transparency and collaborate with the European Medicines Agency to systematically review past rare disease drug applications and regulatory decision-making to expedite approvals. The report advises the EMA and FDA to create a continuously updated public database for these results, and also recommends Congress remove the Pediatric Research Equity Act orphan exemption.

CBD products truly are everywhere these days. From gummies to topical creams and now tampons, it seems there is no limit to where this trendy compound might appear. However, a recent FDA Warning Letter to Anne’s Daye (dba Tampon Innovations) serves as a blunt reminder to medical device manufacturers: you cannot just lace your products with CBD and expect FDA to be mellow about it. CBD products truly are everywhere these days.

The US Food and Drug Administration (FDA), in early January 2025, published a much-anticipated guidance on developing and managing medical devices with artificial intelligence (AI). The Agency recommends taking a total product lifecycle (TPLC) approach to the products to ensure they meet their expectations for safety and efficacy.

FDA’s unpopular LDT final rule could meet its maker when the president-elect hits the oval office, but how is he most likely to upend it?

Officials at the United States Food and Drug Administration (FDA) are reportedly planning to reduce the number of routine inspections carried out by the Office of Inspections and Investigations (OII) after last week’s layoffs due to steep layoffs week in support staff, according to a report late last week by CBS News.

The protective power of genetic mutations discovered in naturally short sleepers: The identification of genetic mutations in natural short sleepers, individuals genetically predisposed to require significantly less sleep without negative health effects, opens the possibility for personalized sleep interventions that could improve health outcomes and quality of life. Recent research indicates that natural short sleepers might effectively clear brain toxins linked to neurodegenerative diseases like Alzheimer’s, suggesting these mutations might offer protective effects.

Alabama woman receives pig kidney transplant: Towana Looney, a 53-year-old from Alabama, became the first living person to receive a kidney transplant from a new type of genetically modified pig in an operation at New York University Langone Health. The FDA has previously allowed transplants of genetically modified pig kidneys and hearts into critically ill patients, who only survived for a short period; however, doctors are more optimistic about Looney’s prognosis due to her healthier condition.

Health and Human Services (HHS) layoffs more employees, shutters offices: HHS has started sending layoff notices that could affect up to 10,000 employees in addition to those who have already left as part of a major reorganization. The workforce reduction and reorganization plan includes consolidating certain Agencies and creating the Administration for a Healthy America. Key leaders at the NIH and FDA have been dismissed or placed on leave, while the CDC is expected to face a significant reduction in staff, particularly in areas not directly related to infectious diseases.

Paul Simon finds hope in animal research for hearing recovery: Musician Paul Simon is seeking scientific remedies for his hearing loss by engaging with researchers at the Stanford Initiative to Cure Hearing Loss, exploring how animals such as zebrafish and mice can regenerate ear hair cells. Researchers are working on gene therapy and drug solutions that could potentially reverse hearing damage.