Promoting, improving and accelerating the drug development and approval processes

While pharma/biotech companies have developed their own tactics for improving R&D productivity and rounding out their pipelines, as discussed elsewhere in this issue, regulatory agencies have in recent years also begun to collaborate with the industry by creating new programs and policies designed to promote, improve and accelerate new drug development and approval. Beginning 26 years ago with the U.S. FDA's Orphan Drug Act, agencies have attempted to revitalize research especially in the areas of untreatable or undertreated disorders through fast-track development and priority review vouchers, and have created programs such as phase 0/microdosing and Quality by Design with the objective of reducing attrition.