FDA in the twenty-first century: the challenges of regulating drugs and new technologies

Abstract

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, 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 -- Prospects or regulation of off-label drug promotion in an era of expanding commercial speech protection / Aaron S. Kesselheim and Michelle M. Mello -- The RDCA as the text for truth of promotional claims / Christopher Robertson -- Why FDA's ban on off-label promotion violates fht 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 enrironment / Geoffrey Levitt -- Innovation policy failures in the manufacturing of drugs / W. Nicholson Price II -- From "Recycle 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 -- 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 addessment 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.