Kooperativer Bibliotheksverbund

UID:

Umfang: xii, 551 Seiten : , Karte.

ISBN: 978-0-231-17118-2

Anmerkung: Literaturangaben und Index. - Sachtitel auf dem Buchrücken: FDA in the 21st century

Weitere Ausg.: Erscheint auch als E-Book ISBN 978-0-231-54007-0

Sprache: Englisch

Schlagwort(e): Aufsatzsammlung

URL: http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028868468&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA

UID:

Umfang: 1 online resource(528 p.) : , illustrations.

Ausgabe: Electronic reproduction. New York, NY : Columbia University Press, 2015. Mode of access: World Wide Web.

Ausgabe: System requirements: Web browser.

Ausgabe: Access may be restricted to users at subscribing institutions.

ISBN: 9780231540070

Inhalt: In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, contributors rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions in other countries.

Anmerkung: Frontmatter -- , Contents -- , Acknowledgments -- , Introduction -- , Chapter One. Historical Themes and Developments at FDA Over the Past Fifty Years -- , PART ONE. FDA in a Changing World -- , Introduction -- , Chapter Two. A Global and Innovative Regulatory Environment for the U.S. FDA -- , Chapter Three. FDA and the Rise of the Empowered Patient -- , Chapter Four. After the FDA: A Twentieth-Century Agency in a Postmodern World -- , Chapter Five. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007 -- , PART TWO. Preserving Public Trust and Demanding Accountability -- , Introduction -- , Chapter Six. Global Trends Toward Transparency in Participant-Level Clinical Trials Data -- , Chapter Seven. Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties -- , Chapter Eight. The Crime of Being in Charge: Executive Culpability and Collateral Consequences -- , Chapter Nine. Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health -- , PART THREE. Protecting the Public Within Constitutional Limits -- , Introduction -- , Chapter Ten. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection -- , Chapter Eleven. The FDCA as the Test for Truth of Promotional Claims -- , Chapter Twelve. Why FDA’s Ban on Off-Label Promotion Violates the First Amendment: A Study in the Values of Commercial Speech Protection -- , PART FOUR. Timing Is Everything: Balancing Access and Uncertainty -- , Introduction -- , Chapter Thirteen. Speed Versus Safety in Drug Development -- , Chapter Fourteen. Overcoming “Premarket Syndrome”: Promoting Better Postmarket Surveillance in an Evolving Drug-Development Context -- , Chapter Fifteen. FDA’s Public Health Imperative: An Increased Role for Active Postmarket Analysis -- , PART FIVE. Old and New Issues in Drug Regulation -- , Introduction -- , Chapter Sixteen. The Drug Efficacy Study and Its Manifold Legacies -- , Chapter Seventeen. Drug Safety Communication: The Evolving Environment -- , Chapter Eighteen. Innovation Policy Failures in the Manufacturing of Drugs -- , PART SIX. Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars -- , Introduction -- , Chapter Nineteen. From “Recycled Molecule” to Orphan Drug: Lessons from Makena -- , Chapter Twenty. FDA, Negotiated Rulemaking, and Generics: A Proposal -- , Chapter Twenty-One. The “Follow-On” Challenge: Statutory Exclusivities and Patent Dances -- , Chapter Twenty-Two. FDA Regulation of Biosimilars -- , PART SEVEN. New Wine in Old Bottles: FDA’s Role in Regulating New Technologies -- , Introduction -- , Chapter Twenty-Three. Analog Agency in a Digital World -- , Chapter Twenty-Four. Twenty-First-Century Technology with Twentieth-Century Baggage: FDA Regulation of Regenerative Medicine -- , Chapter Twenty-Five. Device-ive Maneuvers: FDA’s Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing -- , Chapter Twenty-Six. A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records -- , Chapter Twenty-Seven. Race and the FDA -- , Contributors -- , Index , In English.

Sprache: Englisch

DOI: 10.7312/lync17118

URL: https://www.degruyter.com/doi/book/10.7312/lync17118

URL: https://www.degruyter.com/doi/book/10.7312/lync17118

UID:

Umfang: 1 Online-Ressource (xii, 551 pages)

Ausgabe: Reproduktion New York Electronic reproduction; Available via World Wide Web

ISBN: 9780231540070 , 0231540078

Serie: EBL-Schweitzer

Inhalt: Historical themes and developments at FDA over the past fifty years / Peter Barton Hutt -- FDA in a Changing World. A global and innovative regulatory environment for the U.S. FDA / Howard Sklamberg and Jennifer Devine -- FDA and the rise of the empowered patient / Lewis A. Grossman -- After the FDA : a twentieth-century agency in a postmodern world / Theodore W. Ruger -- The future of prospective medicine under the Food and Drug Administration Amendments Act of 2007 / Barbara J. Evans -- Preserving Public Trust and Demanding Accountability. Global trends toward transparency in participant-level clinical trials data / Alla Digilova, Rebeccs Li, Mark Barnes, and Barbara Bierer -- Conflicts of interest in FDA advisory committees : the paradox of multiple financial ties / Genevieve Pham-Kanter -- The crime of being in charge : executive culpability and collateral consequences / Katrice Bridges Copeland -- Recalibrating enforcement in the biomedical industry : deterrence and the primacy of protecting the public health / Patrick O'Leary -- Protecting the Public Within Constitutional Limits. Prospects for regulation of off-label drug promotion in an era of expanding commercial speech protection / Aaron S. Kesselheim and Michelle M. Mello -- The FDCA as the test for truth of promotional claims / Christopher Robertson -- Why FDA's ban on off-label promotion violates the First Amendment : a study in the values of commercial speech protection / Coleen Klasmeier and Martin H. Redish -- Timing is Everything : Balancing Access and Uncertainty. Speed versus safety in drug development / R. Alta Charo -- Overcoming "premarket syndrome" : promoting better postmarket surveillance in an evolving drug-development context / Shannon Gibson and Trudo Lemmens -- FDA's public health imperative : an increased role for active postmarket analysis / Efthimios Parasidis -- Old and New Issues in Drug Regulation. The drug efficacy study and its manifold legacies / Daniel Carpenter, Jeremy Greene, and Susan Moffitt -- Drug safety communication : the evolving enrironment / Geoffrey Levitt -- Innovation policy failures in the manufacturing of drugs / W. Nicholson Price II -- Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars. From "recycled molecule" to orphan drug : lessons from Makena / Kate Greenwood -- FDA, negotiated rulemaking, and generics : a proposal / Marie Boyd -- The "follow-on" challenge : statutory exclusivities and patent dances / Arti Rai -- FDA regulation of biosimilars / Henry Grabowski and Erika Lietzan -- New Wine in Old Bottles : FDA's Role in Regulating New Technologies. Analog agency in a digital world / Nathan Cortez -- Twenty-first-century technology with twentieth-century baggage : FDA regulation of regenerative medicine / Margaret Foster Riley -- Device-ive maneuvers : FDA's risk assessment of bifurcated direct-to-consumer genetic testing / Elizabeth R. Pike and Kayte Spector-Bagdady -- A new regulatory function for E-Prescriptions : linking FDA to physicians and patient records / Andrew English, David Rosenberg, and Huaou Yan -- Race and the FDA / Jonathan Kahn.

Anmerkung: Includes bibliographical references and index , Electronic reproduction; Available via World Wide Web , English

Weitere Ausg.: ISBN 9780231171182

Weitere Ausg.: ISBN 0231171188

Weitere Ausg.: Erscheint auch als Druck-Ausgabe

Sprache: Englisch

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