LEADER 04270nam 22006015 450 001 9910300340303321 005 20200701171104.0 010 $a3-319-08362-7 024 7 $a10.1007/978-3-319-08362-9 035 $a(CKB)3710000000218681 035 $a(EBL)1802972 035 $a(SSID)ssj0001338705 035 $a(PQKBManifestationID)11857509 035 $a(PQKBTitleCode)TC0001338705 035 $a(PQKBWorkID)11344392 035 $a(PQKB)10989282 035 $a(MiAaPQ)EBC1802972 035 $a(DE-He213)978-3-319-08362-9 035 $a(PPN)180622668 035 $a(EXLCZ)993710000000218681 100 $a20140805d2014 u| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 14$aThe FDA for Doctors$b[electronic resource] /$fby William H. Eaglstein 205 $a1st ed. 2014. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2014. 215 $a1 online resource (98 p.) 300 $aIncludes index. 311 $a1-322-13741-2 311 $a3-319-08361-9 327 $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 (including Phases 1-4, advisory committees, Guidances and personal medicine) -- The FDA and Promotion and Advertising -- The FDA and Drug Names -- The FDA , Politics and the Public. 330 $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, which is regulated by FDA?  Or that FDA itself advertises to try to prevent young people from smoking cigarettes, and that all proprietary drug names must be approved by FDA?  How 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?   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.  Rather, 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 to therapeutics and the many broad societal issues underlying FDA?s activities. With over 40 years of experience as a clinical investigator in many  trials 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.  He has also had the opportunity to serve on the U.S. Senate Labor Committee, helping with its FDA oversight activities.  In addition to a long academic medical career the author has been a consultant to and a full time employee of drug and device companies.    . 606 $aMedicine 606 $aHealth administration 606 $aPharmacy management 606 $aMedicine/Public Health, general$3https://scigraph.springernature.com/ontologies/product-market-codes/H00007 606 $aHealth Administration$3https://scigraph.springernature.com/ontologies/product-market-codes/H27030 606 $aPharmacoeconomics and Health Outcomes$3https://scigraph.springernature.com/ontologies/product-market-codes/H69020 615 0$aMedicine. 615 0$aHealth administration. 615 0$aPharmacy management. 615 14$aMedicine/Public Health, general. 615 24$aHealth Administration. 615 24$aPharmacoeconomics and Health Outcomes. 676 $a353.6 700 $aEaglstein$b William H$4aut$4http://id.loc.gov/vocabulary/relators/aut$0755330 906 $aBOOK 912 $a9910300340303321 996 $aFDA for Doctors$91521926 997 $aUNINA