Elizabeth Mulkey is an associate in Goodwin’s Technology and Life Sciences group and a member of the firm’s FDA practice. She counsels pharmaceutical, medical device, food, and cosmetic companies on FDA regulatory compliance issues, including advertising, promotion and labeling review, drafting and review of standard operating procedures, drug and device approval issues, internal corporate investigations, and responding to FDA enforcement actions. Ms. Mulkey also advises FDA-regulated entities in corporate transactions and offerings.

Areas of Practice
TÄTIGKEITSFELDER
Domaines D’Expertise
业务范围

Experience

ERFAHRUNG

EXPÉRIENCE

工作经历

  • Served as legal reviewer on multiple promotional review committees for pharmaceutical and medical device companies, providing guidance and risk analysis on promotional compliance.*
  • Advised pharmaceutical companies on product acquisition, launch, and co-promotion agreements.*
  • Counseled drug and device companies on Physician Payments Sunshine Act reporting and compliance obligations.*
  • Led in-house compliance training for a pharmaceutical client’s sales force.*
  • Conducted diligence reviews and corporate support for multiple transactions involving healthcare providers.*
  • Presented on FDA enforcement, legal developments in life sciences, and introductory FDA training to industry groups and government employees.* 

* Denotes experience prior to joining Goodwin.

Professional Activities

Ms. Mulkey is a member of the Food and Drug Law Institute and the Life Sciences Practice Group of the American Health Lawyers Association.

In The News

MELDUNGEN

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相关新闻

Credentials

WERDEGANG

RÉFÉRENCES

专业资格

Education

J.D., 2015
Vanderbilt University Law School
B.A., 2012
University of Georgia
(magna cum laude)

Admissions

Bar

District of Columbia
Georgia
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Our clients rely on us for world-class advisory services, counsel on complex transactional work and high-stakes litigation. Specializing in matters involving the financial, life sciences, private equity, real estate, and technology industries, we use a collaborative, cross-disciplinary approach to resolve our clients’ most challenging issues. To find out more, please contact us.

Unsere Kunden verlassen sich auf unsere erstklassige Beratung, vor allem im Hinblick auf komplexe Transaktionen und High-Stakes-Prozesse. Spezialisiert auf Angelegenheiten der Finanz-, Life-Sciences-, Private-Equity-, Immobilien-und Technologie-Branchen, verwenden wir einen kooperativen und interdisziplinären Ansatz, um Fragen unserer Kunden auch in extremen Spezialsituationen einer Lösung zuzuführen. Sie wollen mehr erfahren? Kontaktieren Sie uns gerne.

Nos équipes interviennent aux côtés de nos clients, industriels, fonds d’investissement, startups, institutions financières et dirigeants, dans le cadre de transactions et de contentieux complexes, et apportent des conseils de tout premier plan dans les secteurs financiers, des Sciences de la Vie, du Private Equity, de l’immobilier et des technologies. Nous traitons les dossiers juridiques de manière intègre, ingénieuse, souple et audacieuse pour répondre efficacement aux enjeux propres à chacun de nos clients, quels que soient la taille de l’opération et le secteur d’activité. Pour en savoir plus, contactez-nous.

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