FDA in the Twenty-First Century

Content: 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.