FDA 2002 NME approval times (correction)
Executive Summary
FDA's average approval time for new molecular entities approved in 2002 is 17 months. "The Pink Sheet" (1Jan. 6, p. 10) incorrectly reported that Alliance Pharmaceuticals' Imagent NDA had been resubmitted and therefore miscalculated the approval time average. Imagent (perflexane) was approved in 31.6 months...
You may also be interested in...
FDA Faster Approval Times For 2002 NMEs Aided By Resubmissions
The average total approval time for new molecular entities cleared by FDA in 2002 was 15.2 months, an analysis of new drug approvals shows
Roche/Genentech Keeps Commitment To External Cancer Innovation
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: