Lawyer profile for USA 2021
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Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia
This content is provided by Julie Tibbets
Julie 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 areas of focus include biologics, drugs, medical devices, in vitro diagnostics, lab-developed tests, as well as digital health tools and apps. Ms. Tibbets 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. Ms. Tibbets 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.
JD, University of North Carolina, Chapel Hill, 2004 (Member, Law Review); BA, Purdue University, 2001 (Highest Honors, Phi Beta Kappa).