FDA’s Post-market Safety Reviews Of NMEs Find Timing May Not Be Everything
This article was originally published in The Pink Sheet Daily
Executive Summary
Initial results from pilot show drugs marketed for longer offer more telling data for safety recommendations, but the number of treated patients also may be a factor.
You may also be interested in...
CDER To Launch Application Review Pilot On Data Sharing In FY 2008
One BLA and one NME will be selected by the agency for pilot review before year-end, says CDER Office of New Drugs official.
Big Pharma Still Hopeful For Next Mega Drugs To Supplement Sales
Drug makers need to continue investing in early-stage research to unveil the next $1 billion-plus drug, panelists at the Argyle conference agree.
Affymax's Share Price Stumbles On Questionable Phase III Hematide Data
Phase III data for Affymax/Takeda's anemia drug for chronic kidney failure signals potential regulatory hurdles in non-dialysis use.