The FDA for Doctors de William H. Eaglstein

The FDA for Doctors

Autor William H. Eaglstein

en Limba Engleză Paperback – 19 aug 2014

Publicat sub egida Springer International Publishing, volumul The FDA for Doctors se prezintă într-un format compact de tip paperback, fiind conceput ca o resursă de consultare rapidă pentru medicul clinician. Remarcăm organizarea sa riguroasă în secțiuni care acoperă nu doar medicamentele, ci și dispozitivele medicale, produsele biologice și suplimentele alimentare. Suntem de părere că această structură permite o navigare eficientă prin terminologia vastă a FDA, oferind claritate asupra unor concepte adesea opace pentru practicieni, cum ar fi utilizarea off-label sau mecanismele de aprobare accelerată. Analiza cuprinsului indică o progresie logică, pornind de la relația fundamentală dintre FDA și practica medicală, trecând prin specificul fiecărei categorii de produse și culminând cu procesele de promovare, publicitate și influență politică. Această ediție din 2014 completează titlul FDA Regulatory Affairs de David Mantus prin adăugarea unei perspective clinice directe; în timp ce lucrarea lui Mantus se concentrează pe mecanismele de conformitate industrială, William H. Eaglstein explică modul în care aceste reglementări impactează decizia medicală la patul pacientului. Recomandăm acest volum pentru modul în care demistifică procedurile comitetelor consultative și fazele studiilor clinice, oferind medicilor instrumentele necesare pentru a interpreta critic articolele din presa de specialitate și reglementările care le guvernează profesia.

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Specificații

ISBN-13: 9783319083612
ISBN-10: 3319083619
Pagini: 112
Ilustrații: XI, 97 p. 1 illus. in color.
Dimensiuni: 155 x 235 x 7 mm
Greutate: 0.18 kg
Ediția:2014
Editura: Springer
Locul publicării:Cham, Switzerland

Public țintă

Professional/practitioner

De ce să citești această carte

Recomandăm această carte medicilor care doresc să înțeleagă mecanismele din spatele aprobării tratamentelor pe care le prescriu. Față de alte manuale tehnice, acest ghid este scris de un medic pentru medici, clarificând utilizarea off-label și diferențele dintre medicamente, nutraceutice și cosmeceutice. Este un instrument esențial pentru a naviga cu încredere prin peisajul complex al reglementărilor medicale americane, cu aplicabilitate în înțelegerea standardelor globale.

Despre autor

William H. Eaglstein este un expert recunoscut în domeniul medical, cu o vastă experiență în interfața dintre practica clinică și reglementările guvernamentale. Expertiza sa este adesea solicitată în dermatologie și cercetarea clinică, având capacitatea de a traduce procesele birocratice complexe în termeni relevanți pentru activitatea cotidiană a medicilor. Prin lucrarea sa publicată la Springer, Eaglstein își propune să ofere colegilor săi o bază formală de cunoștințe despre FDA, facilitând o mai bună înțelegere a modului în care agenția influențează inovația și siguranța pacienților.

Descriere scurtă

Many doctors want to know more about the FDA not only so that they might better understand the issues and how they are related to their practice, such as off label-drug usage, but also to enrich their professional lives and allow them to more deeply understand the many FDA related articles written in the popular press. It is further based on the notion that doctors prefer a formal way to learn about FDA. The Agency is a truly vast subject engaging thousands of lawyers, regulators, scientists, physicians, writers, legislators and many others directly and indirectly. This book is an introductory overview written from a physician’s perspective for physicians. It is organized along lines that emphasize issues most interesting to physicians. Much of it deals with nomenclature and definitions, since as is true of all fields, one must understand the special concepts and vocabulary of the field.

Cuprins

Introduction - 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.

Recenzii

“This is an excellent book that explores the question and provides many more details about the FDA. … The physician, to whom this book is directed, will learn about the regulatory process for drugs and how devices differ from drugs, nutraceuticals, and cosmeceuticals … . Dermatologists will find this book to be a fascinating excursion into another part of contemporary medicine.” (Jennifer L. Parish, SKINmed, Vol. 13 (1), January-February, 2015)
“The audience includes clinicians, policymakers, and anyone else who has an interest in how a medication comes to the marketplace. … it does an outstanding job of helping clinicians explain to their patients what they hear in the media and how a medication or device comes to market and how a medication might actually be removed from the market once FDA approval has been obtained.” (Vincent F. Carr, Doody's Book Reviews, December, 2014)

Notă biografică

Dr. Eaglstein is a medical graduate of the University of Missouri, Columbia. After an internship at Kings County Hospital in Brooklyn he completed his dermatology training at the University of Miami follow which he served in the U.S. Navy Medical Corps. He is a past professor and chairman of dermatology at the University of Pittsburgh and the University of Miami, where he is currently chairman emeritus. Since 2004 he has worked in industry at Ivax Pharmaceuticals( President of Ivax Derm), Teva and Stiefel Pharmaceuticals ( Vice President of Research ) and Stiefel a GSK company (Vice President of New Product Assessment and External Research). He is currently an independent consultant, serves on the National Institutes of Arthritis, Musculoskeletal and Skin (NIAMS) Clinical Trials Review Committee and is a volunteer for the Stanford School of Medicine SPARK program. Dr. Eaglstein has been a Robert Wood Johnson Health Policy Fellow, Chairman of an FDA skin advisory panel, Consultant to the FDA OTC division and on the NIAMS NIH National Advisory Panel. He continues his interest in health and regulatory policy. His medical/scientific interests include wound healing, wound care, drug development, skin infections, UV inflammation and inflammatory diseases such as psoriasis and acne.

Textul de pe ultima copertă

This 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 devicecompanies.

Caracteristici

Provides readers with an in-depth understanding of the FDA and those issues related to their practice and to society in general Represents an introductory overview written from a physician’s perspective for physicians Contains detailed explanation of nomenclature and definitions