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Website
- Approval of new drugs when human efficacy studies are not ethical or feasible. Code of Federal Regulations, Title 21, Volume 5, Sections 314.600 and 314.610 (2009). www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=314&showfr=1&subpartnode=21:5.0.1.1.4.9