21 C.F.R. Part 314
Applications for FDA Approval to Market a New Drug
AGeneral ProvisionsBApplicationsCAbbreviated ApplicationsDFDA Action on Applications and Abbreviated ApplicationsEHearing Procedures for New DrugsF[Reserved]GMiscellaneous ProvisionsHAccelerated Approval of New Drugs for Serious or Life-Threatening IllnessesIApproval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible