Lindsay P. Holmes focuses her practice on regulatory and transactional matters, primarily in the healthcare and life sciences industries. She has experience advising clients on Food and Drug Administration (FDA) regulatory matters, including food, drug, device, dietary supplement and cosmetic issues, as well as matters related to 503B outsourcing facilities operating pursuant to the Drug Quality and Security Act (DQSA), and entities subject to the Drug Supply Chain Security Act (DSCSA).
She also has experience assisting clients with matters related to the U.S. Department of Agriculture (USDA) and Drug Enforcement Agency (DEA) compliance. In addition, Lindsay helps pharmacy, wholesaler and third-party logistics provider clients navigate state licensing and pharmacy practice act issues. Her background also includes counseling clients on data privacy and security matters, fraud and abuse, and Medicare Part D.
Experience :
- Advises food and dietary supplement manufacturers related to transactional and compliance matters, including registration, labeling, advertising, inspections, recalls, and FDA and USDA enforcement actions.
- Advises medical device manufacturing companies on registration, compliance, import and export issues, and 510(k) submissions.
- Advises pharmacy, wholesaler and third-party logistics provider clients on state licensing issues and compliance with state pharmacy practice laws.
- Drafts and negotiates pharmacy benefit management agreements and pharmacy participation agreements.
- Working with business associates and covered entities, has drafted data privacy-related agreements, including business associate and data use agreements, and website terms of use and privacy policies.
- Has drafted evidence of coverage documents and insurance applications for compliance with federal and state insurance laws for an insurance company.
- Has counseled human and veterinary pharmaceutical and food manufacturers on issues related to FDA application submissions and import/export customs issues.
Memberships :
- American Health Lawyers Association
- Young Professionals Council: Co-Chair (2018)
- Young Professionals Council: Vice Chair (2017 to 2018)
- Bar Association of the District of Columbia: Health Law Section
- American Society of Pharmacy Law
- Food and Drug Law Institute
Education :
- LL.M., Law and Government, American University, 2014; Certificate in Health Law and Policy; Certificate in Administrative and Regulatory Law
- J.D., University of Miami School of Law, 2011, cum laude
- B.B.A., University of Miami, 2009
Admissions : District of Columbia, Florida.
Cost
Rate : $$$
