TY - BOOK AU - Waksman, Ron TI - The new FDA reality SN - 1878-0938 PY - 2014/// KW - *Clinical Trials as Topic/mt [Methods] KW - *Device Approval KW - *Research Design KW - *United States Food and Drug Administration KW - Clinical Trials as Topic/lj [Legislation & Jurisprudence] KW - Device Approval/lj [Legislation & Jurisprudence] KW - Evidence-Based Medicine KW - Health Policy KW - Humans KW - Patient Safety KW - Research Design/lj [Legislation & Jurisprudence] KW - Risk Assessment KW - Risk Factors KW - Time Factors KW - United States KW - United States Food and Drug Administration/lj [Legislation & Jurisprudence] KW - MedStar Heart & Vascular Institute KW - Editorial N1 - Available in print through MWHC library: 2002 - present UR - http://dx.doi.org/10.1016/j.carrev.2014.01.001 ER -