Overview
Gugan Kaur advises life sciences clients on Food and Drug Administration (FDA) regulatory, compliance and enforcement issues for the full range of FDA-regulated products, from medical devices, dietary supplements and drugs, to cosmetics and food. She also conducts FDA regulatory due diligence, provides risk assessments and relevant provisions and summaries for private equity firms.
Gugan previously served as a Legal Researcher, Drafting and Strategic Engagement Fellow in what was then the FDA Office of International Programs within the Office of the Commissioner. In this role, she assisted the FDA International Arrangements and Disclosure Team in developing international arrangements with foreign governmental regulatory counterparts and international organizations to facilitate the participation of cooperative activities. Today she puts her experience to work guiding clients in identifying and analyzing issues related to premarket and post-market requirements, including clinical trials, current Good Manufacturing Practice (cGMP), marketing and promotion.
Gugan also advises clients on cannabis products, providing guidance on FDA regulatory status, pathways to market, clinical trials, and regulatory implications, as well as issues related to the Federal Trade Commission (FTC), the National Advertising Division (NAD) and the Electronic Retailing Self-Regulation Program (ERSP).
Results
- Conducted internal investigation of the quality and manufacturing operations of the US facilities of a global corporation arising from whistleblower allegations.
- Assisted multiple medical device and digital health developers with product development, labeling, and marketing issues related to the marketing and distribution of various physician and patient-directed mobile medical applications and digital health technologies.
- Assisted a senior executive at a pharmaceutical company in the federal consent decree negotiations arising from alleged violations of FDA current cGMP regulations.
- Advised an industry organization on FDA regulatory status of a patient biometric data aggregation tool for healthcare professionals.
Recognitions
- American Bar Association, Gelhorn-Sargentich Law Student Essay Award, 2016
Community
- Boston University International Law Journal, Editor, 2016
