Vernessa T. Pollard advises companies on regulatory, compliance, enforcement and policy matters involving pharmaceuticals, medical devices, health information technology (HIT) and digital health solutions, services and software. She advises companies and investors on regulatory and compliance issues arising from mergers, acquisitions and other transactions involving Food and Drug Administration (FDA)-regulated products. She also counsels manufacturers, distributors and retailers on regulatory and compliance issues related to food and cosmetic marketing and safety.
Vernessa regularly counsels companies on product development and premarket strategy, Good Manufacturing Practice (GMP) and Quality System (QS) requirements, advertising and promotion, adverse event report FDA warning letters, FDA inspections, recalls, import detentions and corporate compliance programs. She has represented companies and executives in FDA and Department of Justice (DOJ) investigations and enforcement matters. She also conducts due diligence evaluations and analyses of FDA regulatory issues relating to mergers and acquisitions.
Previously, Vernessa spent six years as an associate chief counsel for enforcement in the Office of Chief Counsel at the FDA, where she represented the FDA in a variety of litigation, compliance and regulatory matters. In conjunction with the DOJ, she handled civil injunction and consent decree actions involving pharmaceutical, medical device, food and cosmetic manufacturers. She obtained the FDA's first administrative civil money penalty (CMP) judgment for violations of the Medical Device Report (MDR) requirements. She also handled defensive matters involving FDA regulations and policies for product labeling, advertising and product approval issues arising under the Administrative Procedure Act (APA), the First Amendment, and the Federal Food Drug and Cosmetic Act (FDCA).
While in law school, Vernessa was the managing editor for the Temple Political and Civil Rights Law Review.
Pharmaceutical, Biotechnology and Medical Device Regulatory
FDA and Health Care Due Diligence