Julie Tibbets chairs Goodwin’s FDA practice at the firm. In addition, she co-chairs Goodwin’s firmwide Attorney Review Committee.

Julie focuses her practice on FDA-regulated product development, crisis resolution, product marketing and corporate communications as well as the intersection of each of those with corporate strategy and securities disclosure obligations. Her product areas of focus include biologics, drugs, medical devices, in vitro diagnostics, as well as digital therapeutics, tools and apps. Julie advises clients on product development strategy, interactions with the FDA, clinical trial conduct and documentation, adverse event reporting, commercial strategy, product labeling and advertising, and FDA inspections. She also leads the regulatory due diligence reviews of FDA-regulated M&A or investment targets, potential collaborators and licensees, and guides the regulatory disclosures of FDA-regulated entities in their initial public offerings and follow-on offerings. Julie also works closely with the Food & Healthy Living practice team at Goodwin on the intersection of food, supplement, and cosmetic regulation with FDA’s drug and device authorities.

Areas of Practice
业务范围
Domaines D’Expertise
TÄTIGKEITSFELDER

Experience

工作经历

EXPÉRIENCE

ERFAHRUNG

  • Advises early- to late-stage developers in the drug, device, digital health, and diagnostic areas on product development pathway strategies, regulatory submissions, meetings with the FDA, data disclosures, expedited program designations, patient engagement, disease awareness programs, and corporate communications
  • Counsels numerous public biopharmaceutical companies on the resolution of clinical holds, including those issued following unexpected patient deaths or serious adverse events
  • Counsels the medical affairs and promotional review committees of biologic, drug, medical device, diagnostic, and laboratory companies on managing regulatory risks and ensuring compliant promotional materials and activities across a broad portfolio of products and uses
  • Advises on clinical trial agreements, patient informed consents, and expanded access and right to try policies and programs
  • Conducts internal investigations on regulatory compliance matters, including investigations relating to good clinical practices, product promotion, and drug sampling
  • Counsels on the resolution of Form FDA-483 observations and warning letters
  • Negotiates the regulatory terms of commercial agreements, including pharmacovigilance agreements, clinical collaboration and development agreements, distribution agreements and supply and quality agreements
  • Provides BridgeBio Pharma and its subsidiaries with regulatory counseling in connection with data releases, clinical operations, medical and corporate communications and regulatory disclosures
  • Represented AMAG Pharmaceuticals in the sale of its rights to Intrarosa® to Millicent Pharma for up to $125 million
  • Represented Cerevel Therapeutics on its $350 million underwritten public offering of common stock
  • Represented Valo Health on its $2.8 billion business combination with Khosla Ventures Acquisition Co., a special purpose acquisition company (SPAC) founded by affiliates of Khosla Ventures
  • Represented SpringWorks Therapeutics on regulatory matters in conjunction with its $186.3 million IPO
  • Represented Fresenius Medical Care in regulatory due diligence for its $150 million equity investment in Humacyte, Inc. and exclusive distribution rights for Humacyte’s investigational human acellular vessel, a regenerative medicine product, to dialysis patients worldwide
  • Represented Nautic Partners on its acquisition of Mikart, Inc., a contract development and manufacturing organization

PRO BONO

Julie represents The Fed Is Best Foundation in its national pursuit of regulatory, legislative, and policy changes to set minimum newborn nutritional requirements and to increase parent and health care provider education regarding newborn nutrition and safe feeding practices.

In 2020, Julie began representing VoteRiders, a nonpartisan, nonprofit organization founded in 2012 with a mission to ensure that all citizens are able to exercise their right to vote.

Professional Activities

Julie is a member of the Food and Drug Law Institute, the Society of Clinical Research Associates, and the Drug Information Association.

Recognition

Julie has been ranked in Washington, DC for Pharmaceuticals / Medical Products Regulatory by Chambers USA since 2018. In 2022, LMG Life Sciences recognized Julie as its Regulatory Attorney of the Year: FDA Pharmaceutical. She has appeared on the Washington, DC, Super Lawyers list of “Rising Stars” in the FDA area and has been selected by her peers for inclusion in The Best Lawyers in America every year since 2016 for FDA law.

In The News

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ACTUALITÉS

MELDUNGEN

Credentials

专业资格

RÉFÉRENCES

WERDEGANG

Education

JD, 2004
University of North Carolina, Chapel Hill

(Member, Law Review)

BA, 2001
Purdue University

(Highest Honors, Phi Beta Kappa)

Admissions

Bar

District of Columbia
North Carolina
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