US FDA's Generic Research Projects Appear To Be Opening Way For ANDAs

 
• By Derrick Gingery

Pre-ANDA meeting requests were high in some product categories where FDA conducted research projects, suggesting agency may influence sponsors' development priorities.

FY13-FY17 Linkage of Research To Pre-ANDA Meetings
In some generic product categories where there were many FDA research projects, there also were several pre-ANDA meeting requests, suggesting the studies may have helped sponsors move forward with development. • Source: FDA presentation slides

More from United States

More from North America