News & Publications

Article Amarin v. FDA: Predicting the Future of Off-Label Promotion Pharmaceutical Compliance Monitor
2015Book Chapter 2, Section 3: “Clinical Trials and Clinical Trial Registries” FDA Basics for the Drug and Medical Device Lawyer (DRI)
Article FDA’s Legally-Suspect Shift of Clinical Lab Test Regulation Through Guidance Documents The WLF Legal Pulse
2014Article Regulation of Next Generation Sequencing Journal of Law, Medicine & Ethics 42(3) (Special Supplement)
2013Book Chapter 36: “Role of DTC Companies and Services” Genomic and Personalized Medicine, 2d ed.