The more serious shortages commonly involve sterile injectables.
Areas of focus during phase-out include telehealth and patient access.
Taking stock as the Orphan Drug Act hits its 40-year anniversary.
COVID vaccine development highlights need for modernization.
Sweeping competition initiative drills in on cost reduction.
In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill patients based on early clinical results, Richard Pazdur, director of FDA’s Oncology Center of Excellence, lashed out at the alarmists and urged continued support for this early access process.