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).
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.
Do not send any information or documents that you want to have treated as secret or confidential. Providing information to McDermott via email links on this website or other introductory email communications will not create an attorney-client relationship; will not preclude McDermott from representing any other person or firm in any matter; and will not obligate McDermott to keep confidential the information you provide. McDermott cannot enter into an attorney-client relationship with you until McDermott has determined that doing so will not create a conflict of interest and until you and McDermott have entered into a written agreement or engagement letter that sets forth the terms of our relationship.