Article Summary:
This week’s FDA update includes several significant developments. First, the director of the CDC, Susan Monarez, was fired by President Trump after refusing to resign under pressure from Health and Human Services Secretary Robert Kennedy Jr. Several other top CDC officials also resigned in response. This has led to calls for an investigation into Monarez’s firing, as well as demands for Kennedy’s own dismissal.
The FDA has accepted a proposal to develop a new biomarker for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), which could provide a non-invasive way to assess liver health. Additionally, the agency has extended its Chemistry, Manufacturing, and Controls (CMC) pilot program for another year, aimed at expediting the development of investigational new drugs.
The FDA has also published a study finding that common use of cannabidiol (CBD) products may lead to elevated liver enzymes in healthy adults. Meanwhile, the agency has withdrawn its approval for Amylyx Pharmaceuticals’ Relyvrio drug to treat amyotrophic lateral sclerosis (ALS) at the company’s request.
In the medical device space, the FDA has issued warnings about the risks associated with hyperbaric oxygen therapy devices, and initiated several Class I recalls for infusion systems and ventilators due to potential safety issues.
The text also covers upcoming FDA events, including a workshop on patient-focused drug development and a hearing on the Trump administration’s healthcare agenda featuring HHS Secretary Kennedy.