Julie Tibbets

Julie Tibbets


Goodwin

Recognized since 2016

Washington, District of Columbia

Practice Areas

FDA Law

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Julie Tibbets is a partner in Goodwin’s Technology and Life Sciences group and a member of its FDA practice.Ms. Tibbets focuses her practice on FDA-regulated product development, marketing and corporate communications as well as the intersection of each of those with corporate strategy and securities disclosure obligations. Her product reach spans biologics, drugs, medical devices, in vitro diagnostics, foods, dietary supplements, and cosmetics. Ms. Tibbets advises clients on interactions with the FDA, product formulations, clinical trial documentation, adverse event reporting, commercial strategy, product labeling and advertising. She also leads the regulatory due diligence reviews of FDA-regulated M&A targets, potential collaborators and licensees. Since 2013, Ms. Tibbets has appeared on the Washington, D.C., Super Lawyers list of “Rising Stars” in the FDA area and was selected by her peers for inclusion in The Best Lawyers in America every year since 2016 for FDA law.

Ms. Tibbets is a member of the Food and Drug Law Institute, the Regulatory Affairs Professionals Society, and Drug Information Association. In addition, she pens a regular column in Pharmaceutical Marketing 360 on drug and medical device marketing and communications topics of interest to industry legal, marketing, and regulatory professionals.

Representative experience:

  • Represented Advaxis, Inc., a biopharmaceutical company developing immunotherapies, in a clinical collaboration and licensing deal with Amgen Inc. for a preclinical candidate involving $65 million in upfront cash and equity investment with $475 million in development, regulatory and sales milestones and tiered royalties on net sales.
  • Represented Fresenius Medical Care in FDA regulatory due diligence for its $2.0 billion acquisition of NxStage Medical, Inc.*Counseled the medical affairs and promotional review committees of biologic, drug, medical device, diagnostic and laboratory companies on managing regulatory risks and ensuring compliant materials and activities across a broad portfolio of products and uses.
  • Advised early-stage biopharmaceutical companies on product development strategy, regulatory submissions, clinical hold resolution, clinical development meetings with the FDA and related corporate communications.
  • Negotiated clinical trial agreements, pharmacovigilance agreements, study site letters of indemnification, clinical collaboration agreements and development agreements.
  • Advised biologic, drug, device and diagnostic companies on the application of Physician Payments Sunshine Act reporting requirements to their businesses.
  • Conducted FDA regulatory due diligence reviews of food, drug, device, clinical laboratory and dietary supplement companies and advised clients on the regulatory risk profiles of target companies and business units subject to pending mergers and acquisitions.
  • Advised healthcare providers and distributors on DEA and state reporting requirements for the diversion or loss of controlled substances.
  • Assisted food, dietary supplement and cosmetic manufacturers with new product launches, including review of product branding, labeling, marketing claims and substantiation.

Contact & Links
Location
  • 1900 N Street, NW
    Washington, DC 20036
Education
  • Purdue University, BA
  • The University of North Carolina at Chapel Hill, J.D.
Bar Admissions
  • District of Columbia, United States
  • North Carolina, United States
Affiliations
  • Drug Information Association - Member
  • Food and Drug Law Institute - Member
  • Regulatory Affairs Professionals Society - Member

Goodwin
Headquarters: Boston, Massachusetts

154 The Best Lawyers in America® awards

156 Best Lawyers: Ones to Watch® in America awards

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Recognized in The Best Lawyers in America® 2024 for work in:
  • FDA Law
Additional Areas of Practice:
  • Administrative / Regulatory Law
  • Health Care Law

Experience
  • Counsels the promotional review committees of biologic, drug, device, IVD and laboratory companies on managing regulatory risks and ensuring compliant marketing materials and activities across an array of products and uses.
  • Counsels the promotional review committees of biologic, drug, device, IVD and laboratory companies on managing regulatory risks and ensuring compliant marketing materials and activities across a broad portfolio of products and uses.
  • Advises biologic, drug, device and IVD companies on the application of Physician Payments Sunshine Act reporting requirements to their businesses.
  • Conducts FDA regulatory due diligence reviews of food, drug, device, clinical laboratory and dietary supplement companies and advises clients on the regulatory risk profiles of target companies and business units subject to pending mergers and acquisitions.
  • Advises clinical-stage biopharmaceutical companies on regulatory submissions, clinical development meetings with the FDA and related corporate communications.
  • Represents food manufacturers and retailers on compliance with and implementation of the requirements of the FDA Food Safety Modernization Act and menu labeling requirements.
  • Advises health care providers and distributors on DEA and state reporting requirements for the diversion or loss of controlled substances.
  • Assists food, dietary supplement and cosmetic manufacturers with new product launches, including review of product labeling and marketing claims.

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