Wildy logo
(020) 7242 5778

Wildy’s Book News

Book News cover photo

Vol 22 No 12 Dec 17/Jan 18

Book of the Month

Cover of McGregor on Damages

McGregor on Damages

Edited by: James Edelman, Simon Colton, Jason Varuhas
Price: £440.00

Offers for Newly Called Barristers & Students

Special Discounts for Newly Called & Students

Read More ...

Secondhand & Out of Print

Browse Secondhand Online


Fda in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies (eBook)

Image not available ebook lge
Edited by: Holly Fernandez Lynch, I. Glenn Cohen

ISBN13: 9780231540070
Published: October 2015
Publisher: Columbia University Press
Country of Publication: USA
Format: eBook (ePub)
Price: £55.99 + £11.20 VAT
The amount of VAT charged may change depending on your location of use.

The sale of some eBooks are restricted to certain countries. To alert you to such restrictions, please select the country of the billing address of your credit or debit card you wish to use for payment.

Billing Country:

Sale allowed in
Afghanistan , Albania, Algeria, American Samoa, Andorra, Angola, Anguilla, Antigua and Barbuda, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bermuda, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Cape Verde (Cabo Verde), Cayman Islands, Central African Republic, Chad, Chile, China, Christmas Island, Cocos (Keeling) Islands, Colombia, Comoros, Congo, The Democratic Republic Of The, Cook Islands, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Estonia, Ethiopia, Falkland Islands (Malvinas), Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia, French Southern Territories, Gabon , Gambia, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Grenada, Guadeloupe, Guam, Guatemala, Guernsey, Guinea, Guinea-Bissau, Guyana, Haiti, Heard Island and Mcdonald Islands, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic Of, Iraq, Ireland, Israel, Italy, Ivory Coast (Côte d'Ivoire), Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kiribati, Korea, Democratic Peoples Republic Of, Korea, Republic Of, Kuwait, Kyrgyzstan, Lao Peoples Democratic Republic , Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Macao, Macedonia, The Former Yugoslav Republic Of, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Martinique, Mauritania, Mauritius, Mayotte, Mexico, Micronesia, Federated States Of, Moldova, Republic Of, Monaco, Mongolia, Montenegro, Montserrat, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Niger, Nigeria, Niue, Norfolk Island, Northern Mariana Islands, Norway, Oman, Pakistan, Palau, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Pitcairn, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Saint Barthélemy, Saint Helena , Saint Kitts and Nevis, Saint Lucia, Saint Martin (French part), Saint Pierre and Miquelon, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Georgia and the South Sandwich Islands, Spain, Sri Lanka, Sudan, Suriname, Svalbard and Jan Mayen, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic Of, Thailand, Timor-Leste, Togo, Tokelau, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Turks and Caicos Islands, Tuvalu, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, Vanuatu, Venezuela, Vietnam, Virgin Islands (British), Virgin Islands (U.S.), Wallis and Futuna, Western Sahara, Yemen, Zambia, Zimbabwe

Due to publisher restrictions, international orders for ebooks may need to be confirmed by our staff during shop opening hours. Our trading hours are Monday to Friday, 8.45am to 6.00pm, London, UK time.

Once the order is confirmed an automated e-mail will be sent to you to allow you to download the eBook.

All eBooks are supplied firm sale and cannot be returned. If you believe there is a fault with your eBook then contact us on ebooks@wildy.com and we will help in resolving the issue. This does not affect your statutory rights.

This eBook is available in the following formats: ePub.

In stock.
Need help with ebook formats?

Also available as

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.

Image not available ebook lge
Medical Law, eBooks
Introduction, by Holly Fernandez Lynch and I. Glenn Cohen
1. Historical Themes and Developments at FDA Over the Past Fifty Years, by Peter Barton Hutt
Part 1. FDA in a Changing WorldIntroduction, by Holly Fernandez Lynch
2. A Global and Innovative Regulatory Environment for the U.S. FDA, by Howard Sklamberg and Jennifer Devine
3. FDA and the Rise of the Empowered Patient, by Lewis A. Grossman
4. After the FDA: A Twentieth-Century Agency in a Postmodern World, by Theodore W. Ruger
5. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007, by Barbara J. Evans
Part 2. Preserving Public Trust and Demanding AccountabilityIntroduction, by Christopher Robertson
6. Global Trends Toward Transparency in Participant-Level Clinical Trials Data, by Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer
7. Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties, by Genevieve Pham-Kanter
8. The Crime of Being in Charge: Executive Culpability and Collateral Consequences, by Katrice Bridges Copeland
9. Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health, by Patrick O'Leary
Part 3. Protecting the Public Within Constitutional LimitsIntroduction, by Glenn Cohen
10. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, by Aaron S. Kesselheim and Michelle M. Mello
11. The FDCA as the Test for Truth of Promotional Claims, by Christopher Robertson
12. Why FDA's Ban on Off-Label Promotion Violates the First Amendment: A Study in the Values of Commercial Speech Protection, by Coleen Klasmeier and Martin H. Redish
Part 4. Timing Is Everything: Balancing Access and UncertaintyIntroduction, by W. Nicholson Price II
13. Speed Versus Safety in Drug Development, by R. Alta Charo
14. Overcoming "Premarket Syndrome": Promoting Better Postmarket Surveillance in an Evolving Drug Development Context, by Shannon Gibson and Trudo Lemmens
15. FDA's Public Health Imperative: An Increased Role for Active Postmarket Analysis, by Efthimios Parasidis
Part 5. Old and New Issues in Drug RegulationIntroduction, by R. Alta Charo
16. The Drug Efficacy Study and Its Manifold Legacies, by Daniel Carpenter, Jeremy Greene, and Susan Moffitt
17. Drug Safety Communication: The Evolving Environment, by Geoffrey Levitt18. Innovation Policy Failures in the Manufacturing of Drugs, by W. Nicholson Price II
Part 6. Regulatory Exclusivities and the Regulation of Generic Drugs and BiosimilarsIntroduction, by Benjamin N. Roin19. From "Recycled Molecule" to Orphan Drug: Lessons from Makena, by Kate Greenwood20. FDA, Negotiated Rule Making, and Generics: A Proposal, by Marie Boyd21. The "Follow-On" Challenge: Statutory Exclusivities and Patent Dances, by Arti Rai22. FDA Regulation of Biosimilars, by Henry Grabowski and Erika Lietzan
Part 7. New Wine in Old Bottles: FDA's Role in Regulating New TechnologiesIntroduction, by Frances H. Miller
23. Analog Agency in a Digital World, by Nathan Cortez
24. Twenty-First-Century Technology with Twentieth-Century Baggage: FDA Regulation of Regenerative Medicine, by Margaret Foster Riley
25. Device-ive Maneuvers: FDA's Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing, by Elizabeth R. Pike and Kayte Spector-Bagdady
26. A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records, by Andrew English, David Rosenberg, and Huaou Yan
27. Race and the FDA, by Jonathan KahnContributors