No ice castles here, just cutting-edge AI. The FDA has officially launched Elsa, a generative AI tool built to help staff review clinical protocols, summarize safety data, identify inspection priorities, and even generate code for nonclinical databases.

Under the leadership of Commissioner Marty Makary, M.D., M.P.H., the FDA has achieved remarkable progress in just 100 days, focusing on science, transparency, and common sense to tackle pressing public health challenges.

The pharmaceutical industry continues to operate under the highest standards of scrutiny, especially when it comes to patient safety and manufacturing quality. A recent event involving Granules India Ltd., reported by The Economic Times, offers a valuable opportunity for the broader pharma community to reflect on the evolving demands of global compliance and operational excellence.

The FDA is investigating the tragic death of an 8-year-old boy who received Elevidys, a gene therapy developed by Sarepta Therapeutics for Duchenne muscular dystrophy (DMD). While preliminary reports suggest the cause may not be directly tied to the therapy, potentially related to flu complications worsened by immunosuppressive treatment, the case highlights growing concerns around the safety of AAV-based gene therapies.

The FDA’s latest update on COVID-19 vaccine eligibility is sparking important questions. Beyond the headlines, this decision could reshape both patient access and the strategies guiding our industry.

Somewhere in a factory, a batch of life-saving drugs is ready…… and an inspector is watching over it, from miles away. Welcome to the new era of digital FDA inspections.