Lauren Farruggia is an associate in Goodwin’s Technology and Life Sciences groups and a member of the firm’s FDA regulatory practice. She counsels pharmaceutical, biologic, medical device, digital health, and consumer product companies on FDA regulatory compliance issues, including advertising, promotion, and labeling review, drafting and review of standard operating procedures, drug and device development issues, interactions with FDA, internal corporate investigations, and responding to FDA inspection observations and enforcement actions. Lauren also advises FDA-regulated entities in corporate transactions, offerings, and licensing matters.

Areas of Practice
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Domaines D’Expertise
TÄTIGKEITSFELDER

Experience

工作经历

EXPÉRIENCE

ERFAHRUNG

  • 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.

Professional Experience

In 2016, Lauren interned with the U.S. Department of Justice, Office of Professional Responsibility.

Professional Activities

Lauren is a member of the Food and Drug Law Institute (FDLI)’s New to Food and Drug Law Planning Committee.

Recognition

While in law school, Lauren was a “Sweet Sixteen” finalist in the 2015 Van Vleck Constitutional Law Moot Court Competition. She was also a Senior Member of The Federal Circuit Bar Journal and the Moot Court Board.

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Credentials

专业资格

RÉFÉRENCES

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Education

JD, 2017
The George Washington University Law School
(with honors)
BA, 2012
Allegheny College

Admissions

Bar

District of Columbia
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