9780231171182 hardcover alkaline paper 0231171188 hardcover alkaline paper 9780231540070 electronic book 0231540078 electronic book
Bibliography, etc. Note
Includes bibliographical references and index.
Formatted Contents Note
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.
KF3871 .F34 2015
New York : Columbia University Press,