Sarah Wicks 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 and medical device 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. Ms. Wicks also advises FDA-regulated entities in corporate transactions, offerings and licensing matters.

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Experience

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工作经历

  • Provides strategic advice on matters involving product development and marketing approval, including clinical trial design, expedited pathways, exclusivity and incentives programs.
  • 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.
  • Conducts regulatory due diligence reviews and provides corporate support for mergers, acquisitions and other corporate matters involving FDA-regulated entities.
  • Advises 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.
Professional Activities

Ms. Wicks is a member of Women in Bio and the Food and Drug Law Institute (FDLI).

Professional Experience

While in law school, Ms. Wicks interned at FDA’s Office of Generic Drugs Policy at the Center for Drug Evaluation and Research and the Office of Legislation within the Office of Policy, Planning, Legislation, and Analysis. She also served as a judicial intern at the United States Court of Federal Claims’ Vaccine Claims/Office of Special Masters.

Recognition

In law school, Ms. Wicks received the William P. Cunningham award for her exceptional achievements and service to the law school, particularly for her work as a Student Attorney in the Intellectual Property Clinic, Staff Editor and Symposium Chair for the Journal of Health Law and Policy, Research Assistant to Professor Leslie Meltzer Henry, and a mentor to fellow students interested in food and drug law.

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专业资格

Education

J.D., Health Law and Intellectual Property, 2019
University of Maryland Francis King Carey School of Law
M.P.H., Focus on Clinical Trials & Pharmaceutical Regulations and Policy, 2019
Johns Hopkins Bloomberg School of Public Health
Pharmacoepidemiology and Drug Development Certificate, 2019
Johns Hopkins Bloomberg School of Public Health
B.S., Cell and Molecular Biology, 2014
Towson University
(cum laude)

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District of Columbia
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