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.

Prior to joining Goodwin in 2018, Ms. Tibbets was a partner at Alston & Bird LLP.

Areas of Practice
TÄTIGKEITSFELDER
Domaines D’Expertise
业务范围

Experience

ERFAHRUNG

EXPÉRIENCE

工作经历

  • Represented Morgan Stanley & Co. LLC in its underwriting of a $276 million follow-on public offering of Immunomedics, Inc. shares.
  • Represented Fresenius Medical Care in FDA regulatory due diligence for its $150 million equity investment in Humacyte, Inc. and exclusive distribution rights for Humacyte’s investigational human acellular vessel to dialysis patients worldwide.
  • 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, expedited program eligibility, expanded access and “right-to-try” access, 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 manufacturers, healthcare providers and distributors on DEA and state controlled substance registration and 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.

PRO BONO

Ms. Tibbets 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.

Professional Activities

Ms. Tibbets is a member of the Food and Drug Law Institute, the Regulatory Affairs Professionals Society, and the Drug Information Association.

Recognition

Ms. Tibbets was selected as an “Up and Coming” lawyer in Washington, D.C. for Pharmaceuticals / Medical Products Regulatory by Chambers USA 2018. Since 2013, she 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.

In The News

MELDUNGEN

ACTUALITÉS

在新闻中

Credentials

WERDEGANG

RÉFÉRENCES

专业资格

Education

J.D., 2004
University of North Carolina, Chapel Hill

(Member, Law Review)

B.A., 2001
Purdue University

(Highest Honors, Phi Beta Kappa)

Admissions

Bar

District of Columbia
North Carolina
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