FDA in the twenty-first century : the challenges of regulating drugs and new technologies / edited by Holly Fernandez Lynch and I. Glenn Cohen.

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Bibliographic Details
Other Authors: Lynch, Holly Fernandez (Editor), Cohen, I. Glenn (Editor)
Other title:Food and Drug Administration in the twenty-first century : the challenges of regulating drugs and new technologies.
FDA in the 21st century.
Format: Book
Published: New York : Columbia University Press, [2015]
Table of Contents:
  • Historical themes and developments at FDA over the past fifty years / Peter Barton Hutt
  • 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
  • Global trends toward transparency in participant-level clinical trials data / Alla Digilova, Rebecca 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
  • 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
  • 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
  • The drug efficacy study and its manifold legacies / Daniel Carpenter, Jeremy Greene, and Susan Moffitt
  • Drug safety communication : the evolving environment / Geoffrey Levitt
  • Innovation policy failures in the manufacturing of drugs / W. Nicholson Price II
  • From "recycled molecule" to orphan drug : lessons from Makena / Kate Greenwood
  • FDA, negotiated rule making, 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
  • 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.