The RAPS learning platform provider will be upgrading its security posture. This will take the system off-line from 20 July through the end of the day 23 July. This will affect any Online Course, eBook, and Virtual Program Attendance. Thank you for your patience.
Regulatory Update: Pending and New Guidance
Posted 01 March 2009 | By
This draft guidance provides information on the development of animal efficacy models under the "Animal Rule" (21 CFR 314.600 for drugs; 21 CFR 601.90 for biologics). The Animal Rule is the means by which FDA marketing approval may be granted based on animal efficacy data when human efficacy testing is neither ethical nor feasible.