- Serves as legal reviewer on internal promotional review and medical legal regulatory (MLR) committees for pharmaceutical and medical device companies, providing legal assessment and analysis of publications, social media posts, medical affairs materials, sales training materials, commercial outreach plans, and print and digital launch and promotional materials.
- Provides extensive review of corporate communications and regulatory disclosures in securities filings for pharmaceutical and medical device companies across the preclinical to commercial stages, including for corporate presentations, press releases, exhibit booth content, and communications with patient advocacy groups.
- Counsels on company responses to FDA advisory and enforcement letters and responses to FDA Form 483 inspection observations.
- Conducts regulatory due diligence reviews and provides corporate support for M&A transactions, private equity investments, individual investments and licensing deals involving FDA-regulated entities, including healthcare and digital health companies.
- Advises on the regulatory classification of over-the-counter drug and medical device products and allowable marketing and labeling claims for such products.
- Reviewed available literature to advise pharmaceutical and medical device companies on the utilization of additional claims and data by sales or medical affairs teams, including from real-world evidence studies.
- Led in-house compliance training for a pharmaceutical client’s sales force.*
* Denotes experience prior to joining Goodwin.
Ms. Mulkey is a member of the Food and Drug Law Institute (FDLI) and is a frequent speaker at FDLI training events for new FDA employees.