Pilot Program Will Review First-Year Safety Data for Several NMEs
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA outlines organizational steps and safety monitoring initiatives in response to IoM report on improving drug safety.
You may also be interested in...
FDA Makes Post-Market Safety Evaluation Comprehensive For All NMEs, BLAs
All new molecular entities and BLAs approved since Sept. 27, 2007, will be subject to the comprehensive post-market safety evaluation process that FDA pilot-tested during the past two years
FDA Makes Post-Market Safety Evaluation Comprehensive For All NMEs, BLAs
All new molecular entities and BLAs approved since Sept. 27, 2007, will be subject to the comprehensive post-market safety evaluation process that FDA pilot-tested during the past two years
Ketek Act I: FDA Updates Label, Touts Process On Eve Of Hearing
Agency says it has “learned” from controversy surrounding the antibiotic, but FDA will likely still face congressional grilling about its actions.