Rebecca H. Williams
Associate
Rebecca Williams focuses her practice on FDA regulatory matters and advises life sciences and health care clients on a broad range of issues under the Food, Drug and Cosmetics Act and related laws. Rebecca conducts regulatory due diligence for corporate transactions and public offerings involving drug, device, dietary supplement and food companies. Rebecca maintains an active pro bono practice with a focus on immigration and healthcare issues.
During law school, Rebecca drafted and argued a civil appeal before the Michigan Court of Appeals as a student attorney for University of Michigan’s Child Welfare Appellate Clinic. Rebecca also worked for the Network for Public Health Law, drafting profiles of state public health codes and related laws and regulation.
Experience
Transactional Support
- Routinely perform FDA regulatory diligence for private equity funds’ acquisition of drug, medical device, and food companies.
- Routinely perform FDA regulatory diligence for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotech companies.
- Advised a medical device client regarding issues related to recall and regulatory reporting decisions.
Promotional Compliance
- Routinely assess regulatory compliance of advertising and promotional materials for pharmaceutical, biotech, medical device, and food companies.
- Served as the legal reviewer on a biotech client’s promotional review committee.
- Performed an assessment of a pharmaceutical client’s promotional review committee, which involved employee interviews, reviewing SOPs and other internal documents, evaluating a sampling of promotional materials used by the company, and providing recommendations for improvement.
General Regulatory
- Frequently advise pharmaceutical and medical device clients in connection with licensing and supply agreements.
- Advised pharmaceutical clients on issues related to Hatch-Waxman, orphan drug exclusivity, and new chemical entity exclusivity.
- Advised a pharmaceutical client regarding its response to a Warning Letter alleging current Good Manufacturing Practices violations.
- Advised a medical device client regarding requirements for medical device distribution and use under state law.
Publications
- Co-author, “Proposed FDA Drug Software Rules Strict On Pharma Companies,” Law360 (December 10, 2018)
- Co-author, “How States, Federal Agencies Are Challenging Drug Prices,” Law360 (April 23, 2018)
- Co-author, “The Latest FDA Move To Limit Digital Health Software Regs,” Law360 (December 21, 2017)