000707409 000__ 02528cam\a2200445Ii\4500 000707409 001__ 707409 000707409 005__ 20230306140040.0 000707409 006__ m\\\\\o\\d\\\\\\\\ 000707409 007__ cr\cnunnnunuuu 000707409 008__ 140815t20142014sz\\\\\\o\\\\\001\0\eng\d 000707409 020__ $$z9783319083612 000707409 020__ $$a9783319083629$$qelectronic book 000707409 020__ $$a3319083627$$qelectronic book 000707409 035__ $$aSP(OCoLC)ocn887245252 000707409 035__ $$aSP(OCoLC)887245252 000707409 040__ $$aN$T$$beng$$erda$$epn$$cN$T$$dGW5XE$$dYDXCP$$dCOO 000707409 043__ $$an-us--- 000707409 049__ $$aISEA 000707409 050_4 $$aRA401.A3 000707409 08204 $$a362.17820973$$223 000707409 1001_ $$aEaglstein, William H.,$$d1940-$$eauthor. 000707409 24514 $$aThe FDA for doctors$$h[electronic resource] /$$cWilliam H. Eaglstein. 000707409 2463_ $$aFood and Drug Administration 000707409 264_1 $$aCham :$$bSpringer,$$c[2014] 000707409 264_4 $$c©2014 000707409 300__ $$a1 online resource. 000707409 336__ $$atext$$btxt$$2rdacontent 000707409 337__ $$acomputer$$bc$$2rdamedia 000707409 338__ $$aonline resource$$bcr$$2rdacarrier 000707409 500__ $$aIncludes index. 000707409 5050_ $$aDoctors and the FDA -- What Are Drugs? -- What Are Devices? -- What Are Biologics, Biological Products and Biological Drugs? -- What Are Combination Products? -- What Are Dietary Supplements and Nutraceuticals? -- What Are Cosmetics and Cosmeceuticals? -- What Is the FDA and What Does It Do? -- Foods, Doctors and the FDA -- The FDA Approval Process and Drug Development -- The New Drug Application (NDA), the Investigative New Drug Exemption (IND) and the General Drug Approval Pathway -- FDA and Tobacco Products -- FDA Advisory Committees -- FDA, Labels and Labeling for Medical Products -- FDA and Product Names -- FDA and Promotion and Advertising -- Off-Label Use -- Additional Drug Approval Pathways and Expanded Access (Treatment INDs); and Personal Importation of Unapproved Drugs -- FDA Exclusivity and Patents -- Adverse Event Reporting, Pharmacovigilance and FDA -- FDA Rule Making and Guidances -- Enforcement and Warning Letters -- The FDA, Politics and Criticism -- Brief History of the FDA. 000707409 506__ $$aAccess limited to authorized users. 000707409 588__ $$aDescription based on print version record. 000707409 61010 $$aUnited States.$$bFood and Drug Administration. 000707409 650_0 $$aPharmaceutical policy$$zUnited States. 000707409 77608 $$iPrint version:$$aEaglstein, William H.$$tFda for doctors$$z3319083619$$w(OCoLC)880965605 000707409 85280 $$bebk$$hSpringerLink 000707409 85640 $$3SpringerLink$$uhttps://univsouthin.idm.oclc.org/login?url=http://dx.doi.org/10.1007/978-3-319-08362-9$$zOnline Access 000707409 909CO $$ooai:library.usi.edu:707409$$pGLOBAL_SET 000707409 980__ $$aEBOOK 000707409 980__ $$aBIB 000707409 982__ $$aEbook 000707409 983__ $$aOnline 000707409 994__ $$a92$$bISE