Will Tenbarge

Will Tenbarge

Associate Global Regulatory

Washington, D.C.

+1 202 804 7849

[email protected]

Will Tenbarge

Overview
Experience
Credentials
Insights and events

Will Tenbarge brings a business-minded approach to helping pharmaceutical and biotechnology clients balance risk while facing a complex legal and regulatory landscape.

Will's practice includes advising on a broad range of FDA regulatory matters, including responding to FDA enforcement actions and related government investigations, reviewing and vetting advertising and promotional compliance programs, and managing the post-market lifecycle of pharmaceutical and biotechnology products. He also leverages his background in accounting and finance to advise on FDA issues related to corporate transactions and public filings with the SEC.

Will also serves as the Pro Bono Champion for the Pharmaceutical and Biotechnology practice group. He maintains an active Pro Bono practice representing individual survivors of domestic violence in court; assisting Afghan and Ukrainian nationals with humanitarian and immigration matters; and providing analysis for initiatives focused on gun control, public health, voting rights, criminal justice, and privacy.

Prior to joining Hogan Lovells, Will worked at a Big 4 accounting firm to provide risk and compliance consulting services to clients across life sciences, finance, real estate, and insurance industries.

Representative experience

Assist multiple pharmaceutical and biotechnology companies in responding to FDA enforcement letters and Form FDA 483 inspectional observations by designing and implementing enhanced internal controls.

Draft Citizen Petitions regarding FDA standards for demonstrating equivalence between various generic and brand-name products.

Advise clients in responding to qui tam complaints brought under the False Claims Act regarding drug quality and safety claims.

Perform comprehensive assessments of regulatory compliance programs and assist with implementing updated policies and training.

Assist a large pharmaceutical client in revamping its clinical operations program, including fine-tuning procedures and forms on informed consent, conflicts of interest, recruitment, and trial design.

Assist pharmaceutical and biotechnology firms navigate dispute resolution, administrative hearing, advisory committee procedures with FDA.