| Biography | Vernessa Thomas Pollard advises pharmaceutical, biotech, medical device, food, and cosmetic companies and other clients on FDA regulatory matters including: US Food and Drug Administration (FDA) and US Department of Justice (DOJ) investigations and other enforcement matters, corporate compliance policies and post-market compliance strategies, advertising and promotional issues, product approval issues, Risk Evaluation and Mitigation Strategies (REMs), Good Manufacturing Practice (GMP) and Quality System (QS) requirements, recalls, and FDA import issues. Managing Editor, Temple Political and Civil Rights Law Review, 1998-1999. Associate, Pepper Hamilton LLP, 1999-2002. Associate Chief Counsel for Enforcement, Office of Chief Counsel, FDA, 2002-2008. FDA Commissioner's Award of Excellence, 2008. HHS, Secretary's Award for Distinguished Service, FDA Ephedra Rulemaking and Litigation, 2005. FDA Commissioner's Outstanding Service Award for Outstanding Legal Representation and Dedication in Conducting Enforcement and Defensive Litigation, 2005. Speaker: Marketing FDA-regulated Products In the Era of Social Media: What You Need to Know to Expand Your Message, Remain Compliant, and Manage Your Risks," Thompson Interactive Audio Conference, August 2010. Speaker: FDA Clinical Research Enforcement and Compliance Issues in a Global Market," International BIO Convention, May 2010. Speaker: Co-Author, "FDA's Evolving Civil Money Penalty Authority: Simple Violations Can Lead to Major Costs," GxP Lifeline Pharmaceutical, June 2009. Speaker: "Postmarket Requirements and Concerns for Medical Devices," American Conference Institute's FDA Boot Camp: Basic Training for Products Liability and Patent Lawyers, 2009. "Introduction to the US Drug Regulatory Process," Food and Drug Law Institute/Center for Drug Evaluation and Research / In-House Training, 2009. "Product Safety in North America: Emerging US Initiatives for Assuring Product Safety in the Era of Globalization," American Bar Association Section of International Law Spring Meeting, 2009. |
Documents by this lawyer on Martindale.com | |
FDA Issues Draft Guidance Regarding Mobile Medical "Apps"Joseph W. Cormier,Vernessa T. Pollard, July 25, 2011 On July 19, 2011, the US Food and Drug Administration (FDA) published a Draft Guidance on Mobile Medical Applications (the Draft Guidance). The Draft Guidance is the latest in a growing list of FDA rules and guidelines, which signal FDA’s intent to actively regulate and monitor mobile medical... |