Statement From Lilly And Avid On FDA Advisory Committee Recommendation For Amyvid (Florbetapir) NDA
The U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee decided today that it could not recommend approval of Amyvid (florbetapir) at this time based on the currently available data (13-3); but, voted unanimously (16-0) to recommend approval of Amyvid conditional on a reader training program that demonstrates reader accuracy and consistency ...

Trade group cautiously upbeat on FDA plan
The FDA's plan for reforming the 510(k) program looks good on paper, but it's impact on the cost and time required for regulatory approvals is still unclear, said AdvaMed.