Lauren Farruggia

• 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.

Lauren is a member of the Food and Drug Law Institute (FDLI)’s Webinar Programs Committee.

While in law school, Lauren was a “Sweet Sixteen” finalist in the Van Vleck Constitutional Law Moot Court Competition. She was also a Senior Member of The Federal Circuit Bar Journal and the Moot Court Board.

Lauren’s recent presentations have included:

• "Food Labeling: Ready to Launch Workshop," Commonwealth Kitchen, May 30, 2023
• "Dealing with Adverse Events and Product Problems," FDLI/CDRH In-House Training Course: Introduction to Medical Device Law and Regulation, May 11, 2023
• "The New Drug Approval Process: NDA Submission and Review,” FDLI Introduction to Drug Law and Regulation, November 9, 2022
• “Food Labeling: Regulatory Considerations Workshop”, Lawyers for Civil Rights, July 7, 2022
• “Food Labeling: Ready to Launch Workshop,” Commonwealth Kitchen, May 24, 2022

Prior to joining Goodwin, Lauren’s speeches and presentations included:

• “FDA Regulation of CBD and Compliance Considerations,” The Kentucky Journal of Equine, Agriculture, and Natural Resources Law, Issues in Marijuana Law Symposium, February 26, 2021
• “FDA Inspections and Enforcement,” FDLI Introduction to Tobacco and Nicotine Products Law and Regulation, October 20, 2020
• Co-Presenter, “Ethically Speaking: Issues and Uncertainties in Practicing Cannabis Law,” FDLI Food Advertising, Labeling, and Litigation Conference, September 27, 2019
• Co-Presenter, “Developments in FDA Software Regulation,” FDLI New to Food and Drug Law Group, October 11, 2018

Lauren’s publications include:

• Author, “Supporting Innovation Through FDA’s Breakthrough Device Program,” PM360, 12.15.22
• Co-Author, “Significant Regulatory, Compliance, and Enforcement Developments, 2021,” Top Food and Drug Cases, 2021, & Cases to Watch, 2022, 90-95, 2022
• Co-Author, “Significant Regulatory, Policy, and Enforcement Developments: 2020 A Tale of the Three C’s: COVID-19, Cannabis, and CBD,” FDLI Food and Drug Cases, 2020, & Cases to Watch, 2021, 78-82, 2021
• Co-Author, “Significant Regulatory, Policy, and Enforcement Developments, 2019,” FDLI Top Food and Drug Cases, 71-84, 2020
• Co-Author, “CBD Scrutiny May Signal Broader FDA Enforcement Trend,” Law360, April 9, 2019
• Co-Author, “Cheers to 80 Years 80 Years Of The Food, Drug, And Cosmetic Act,” Law360, June 22, 2018
• Co-Author, “The “New” NDC: Are You Aware of FDA’s Rollout of the New Unique Medical Device Identified (UDI) and Its Potential Future Impact on Payer Claims Forms?,” FDLI Update, September/October 2017