Expediting Drug Approval
Cardinal Health Regulatory Sciences
For patients with serious and rare diseases, time is of the essence, and the traditional drug development process may take far too long. To speed innovative new drugs to market, the FDA has established four expedited programs that allow the development process to be compressed and evidence of the drug’s effectiveness gathered as efficiently as possible. This white paper takes a closer look at the programs, how products qualify, and the critical steps companies need to take to successfully work with FDA to accelerate their approval.