- Serves as legal reviewer on internal medical and promotional review boards for pharmaceutical companies, providing legal assessment and analysis of market research, 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, medical meetings, and exhibit booths
- Conducts regulatory due diligence reviews and provides corporate support for mergers, acquisitions, and other corporate matters involving FDA-regulated entities
- Counsels on company responses to FDA advisory and enforcement letters and responses to Form FDA 483 inspection observations
- Advises manufacturers on the regulatory compliance and enforcement landscape for food, dietary supplement, tobacco*, over-the-counter drug, and medical device products and allowable marketing and labeling claims for such products
- Advised on the federal and state regulatory status of hemp-derived CBD products, including product-specific labeling and registration requirements and manufacturer and distributor licensing/registration requirements*
*Denotes experience prior to joining Goodwin.
In 2016, Lauren interned with the U.S. Department of Justice, Office of Professional Responsibility.
Lauren is a member of the Food and Drug Law Institute (FDLI)’s New to Food and Drug Law Planning Committee.