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Overview

Bianca Lewis’ broad transactional and regulatory practice focuses on matters at the intersection of technology, media, advertising and data privacy, with a special interest in life sciences. As part of her broad practice, she advises clients on a wide array of complex privacy, data security and FDA and health care regulatory issues. She works with clients across a diverse range of industries, including life sciences, biopharmaceuticals, health care, medical devices, consumer products, entertainment, media, software and technology. 

Bianca has extensive experience guiding clients through U.S. and global data privacy laws and regulations, including the GDPR, HIPAA, CCPA and CPRA. She helps companies navigate health privacy issues, advertising compliance and the implementation privacy programs to ensure operational compliance with evolving regulations. Notably, Bianca assists multinational pharmaceutical companies with HIPAA privacy compliance also counsels clients on responding to data breaches response and mitigation and developing proactive strategies to mitigate risks.

In her FDA regulatory practice, Bianca provides strategic guidance claims substantiation, medical device compliance, dietary supplement requirements and tobacco product regulations.

In addition, as part of her mergers and acquisitions practice, Bianca also advises on the privacy and FDA regulatory considerations for acquisitions, helping clients assess compliance risks and obligations, and navigate regulatory pathways to strategically address both operational and legal complexities.

Select examples of representative FDA regulatory experience include:

  • Advocated on behalf of a leading national manufacturer to successfully resolve a dispute over the FDA regulatory status of one of its flagship products. 
  • Advising an underwriter client on complex FDA regulatory compliance issues for a proposed IPO of a multi-national client in a highly-regulated industry. 
  • Advised acquirer on FDA regulatory clearance and compliance issues in a proposed merger with a medical device company. 
  • Advised a SPAC acquirer on FDA regulatory approval pathways and compliance issues in connection with a merger with a biopharmaceutical company with clinical stage Orphan Designated biologic drug candidates.
 

Education

  • New York Law School, J.D.
  • SUNY Old Westbury, B.A., cum laude

Bar Admissions

  • New York

Recognition

  • Named to Best Lawyers: Ones to Watch list in Financial Services Regulation Law (2021-2025) and Health Care Law (2023-2025)

Affiliations

  • Member, American Bar Association
  • Judicial Intern, The Honorable Judge Michael A. Shipp, U.S. District Court for the District of New Jersey