PhRMA, Patient Orgs Eye Remote Trial, Digital Health Expansion in PDUFA

The brand drug lobby and patient groups say the next iteration of prescription drug user fee legislation should expand use of decentralized clinical trials and digital health technologies that can collect data remotely. Decentralized trials, which have become more widespread during the COVID-19 pandemic, can make trials more accessible to patients, including those within the rare disease community, patient organizations say. FDA and lawmakers recently ramped up discussions around the future of decentralized trials. The agency paved the way for...