Book Chapters
Corporate Integrity Agreements, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 97 (Oxford University Press, 2009)
Deferred Prosecution and Non-Prosecution Agreements, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 119 (Oxford University Press, 2009)
Understanding and Complying with Compliance Agreements, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 155 (Oxford University Press, 2009)
Remedies of Disgorgement and Restitution, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 181 (Oxford University Press, 2009)
FDA Regulation of Drugs, in Nanotechnology & FDA-Regulated Products: The Essential Guide 43 (Food and Drug Law Institute, 2009)
FDA Regulation of Medical Devices, in Nanotechnology & FDA-Regulated Products: The Essential Guide 75 (Food and Drug Law Institute, 2009)
Journal Articles
Defining Chemical Action under the FDCA: A New Approach to Evolving Science, Journal of Law, Science and Technology (forthcoming 2009) (with Kooladge & Anand)
Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanotechnology, Journal of Law, Medicine & Ethics (forthcoming 2009) (with Jordan Paradise, Alison W. Tisdale & Efrosini Kokkoli)
Developing Oversight Frameworks for Nanobiotechnology, 9 Minnesota Journal of Law, Science & Technology 399 (2008) (with Jordan Paradise, Susan M. Wolf, Gurumurthy Ramachandran, Efrosini Kokkoli & Jennifer Kuzma)
Leaving No Child Behind? Abigail Alliance, Pediatric Products and Off-label Use, 8 Houston Journal of Health Law & Policy 271 (2008) (with Tracy A. Braun)
Does the Constitution Provide a Right of Access to Experimental Drugs?, 11 Journal of Nursing Law 210 (2007)
Inconsistent Government Policies: Why FDA Off-Label Regulation Cannot Survive First Amendment Review under Greater New Orleans, 62 Food and Drug Law Journal 263 (2007) (with Elizabeth S. Sobotka)
The Risk of Risk Reduction: Can Postmarket Surveillance Pose More Risk than Benefit?, 62 Food and Drug Law Journal 473 (2007)
When You Have a Hammer Everything Looks Like a Nail: Misapplication of the False Claims Act to Off-Label Promotion, 61 Food and Drug Law Journal 653 (2006) (with Robert J. Berlin)
A Proposed Solution to the Notification Problem, 7 Minnesota Journal of Law, Science & Technology 189 (2005)
To Recall or Not to Recall, That Is the Question: The Current Controversy over Medical Device Recalls, 7 Minnesota Journal of Law, Science & Technology 161 (2005)
Other Publications
The Decline of the DPA: What Has Happened and Why, Update 50 (Issue 2, Mar./Apr. 2009) (with Timothy Schmidt)
Weaning FDA, Congress and Industry from User Fees, Update (Issue 3, May/June 2007) (with Robert J. Berlin)
The Next Enforcement Target: Your Company's Compliance Office, Update 30 (Issue 6, Nov./Dec. 2006)
Access to Experimental Drugs, A New Constitutional Right?, Update 11 (Issue 5, Sept./Oct. 2006) (with Colleen M. Roberts)
"Off-label" Speech: Uncertainty Reigns for Device and Drug Makers, 20 Legal Backgrounder (Washington Legal Foundation) (Dec. 2, 2005)
