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FDA in the twenty first century the challenges of regulating drugs and new technologies 1st Edition by Holly Fernandez Lynch, I Glenn Cohen ISBN 0231171188 9780231171182

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FDA in the twenty first century the challenges of regulating drugs and new technologies 1st Edition Cohen Digital Instant Download

Author(s): Cohen, I. Glenn; Lynch, Holly Fernandez
ISBN(s): 9780231171182, 0231171188
Edition: 1
File Details: PDF, 2.64 MB
Year: 2015
Language: english
SKU: EB-5268812 Category: Tags: , , ,

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ISBN 10: 0231171188 
ISBN 13: 9780231171182
Author: Holly Fernandez Lynch, I Glenn Cohen

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, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

FDA in the twenty first century the challenges of regulating drugs and new technologies 1st Table of contents:

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

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Tags: Holly Fernandez Lynch, I Glenn Cohen, FDA, regulating drugs