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008			140805s2014 gw | s |||| 0|eng d
020			_a9783319083629
024	7		_a10.1007/978-3-319-08362-9 _2doi
050		4	_aRA401.A3 _bE245 2014
100	1		_aEaglstein, William H. _988625 _0Local
245	1	4	_aThe FDA for Doctors _cby William H. Eaglstein.
260			_aCham, Switzerland _bSpringer _c2014
300			_a1 recurso en línea (XI, 97 páginas) _b1 ilustraciones en color
336			_aTexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
505	0		_aIntroduction - The FDA, Doctors and the Practice of Medicine -- Drugs -- Devices -- Biologics -- Combination Products -- Supplements and Neutraceuticals -- Foods -- Cosmetics and Cosmeceuticals -- The FDA (history, organization, budgets) -- The Approval Process (includingÂ{u0A21}ses 1-4, advisory committees, GuidancesÂ{u1BA4} personal medicine) -- The FDA and Promotion and Advertising -- The FDA and Drug Names -- The FDA , Politics and the Public.
520	3		_aThis book explains the Food and Drug Administration (FDA) as an institution and provides understanding of its nomenclature, societal role, policies, goals and challenges. While many readers will have some knowledge of the FDA, few have an appreciation of the many specific areas of FDA authority. For example, how many realize that the US is one of only two countries which allow direct-to-consumer drug advertising,Â{u7A29}ch is regulated by FDA?Â{u03F2} that FDA itself advertises to try to prevent young people from smoking cigarettes, and that all proprietary drug names must be approved by FDA?Âȯw many doctors or other readers are familiar with the formal definition distinguishing drugs from devices and the importance this has for development costs and for our knowledge about the ultimate products?Â{u2820} How many know how much nutritional supplements are regulated by FDA? The FDA for Doctors is not for those looking for detailed instruction on dealing with the FDA or its operations. Â{u2874}her, it is written by a doctor with doctors in mind, with the hope that the information in this book will make physicians, and other readers, more thoughtful and insightful, especially with regards toÂ{u4A25}rapeutics and the many broad societal issues underlying FDAâ€{u3821}ctivities. With over 40 years of experience as a clinical investigator in manyÂ{u0D32}ials done for FDA registration, the author has been a member of and chaired an FDA advisory committee, and has been a consultant to several divisions of the FDA.Â{u0225} has also had the opportunity to serve on the U.S. Senate Labor Committee, helping with its FDA oversight activities. Â{u9BA0} addition to a long academic medical career the author has been a consultant to and a full time employee of drug and device companies.Â{u2820} Â{uE000}
710	2		_aSpringerLink (Online service) _0Local _9106996
942			_2lcc _cLE
988			_aEBOOK, EBSPRINGER, asignarmaterias_11febrero
650		7	_aPráctica médica _0 _2embne _9437382
650	2	7	_aCentros de salud _0 _2embne _9155517
650	2	7	_aIndustria farmacéutica _0 _2embne _9138366
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-3-319-08362-9 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
907			_a.b12881971 _b10-10-17 _c11-11-15
998			_am _a_alco _a_vill _b11-11-15 _cm _dz _e- _feng _ggw _h4
945			_aRA401.A3 E245 2014 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11561798 _z06-04-17
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