Liberti L, Breckenridge A, Eichler HG, Peterson R, McAuslane N, Walker S. Expediting patients’ access to medicines by improving the predictability of drug development and the regulatoryapproval process. Clin Pharmacol Ther. 2010 Jan;87(1):27-31.
Ideally, well-designed global pharmaceutical development programs that include simultaneous submissions to multiple regulatory agencies can result in predictable regulatory approvals and expedited access to medicines for all patients. The workshops described herein investigated current trends indevelopment and submission strategies along with regulatory review performance data in order to consider whether barriers to predictable expeditedapproval outcomes can be overcome through innovative clinical development approaches and a better understanding of review processes and procedures, particularly as these relate to the assessment of a product’s risk-benefit profile.