Perfil
Nicole is an attorney with Greenberg Traurig's Health Care & FDA Practice in Washington, DC. She primarily advises drug, device, food, and cosmetic manufacturers and distributors on how to comply with state and federal regulatory requirements related to FDA registration/listing, state licensure, product labeling, marketing claims, and safety monitoring/reporting. Nicole provides feedback on labeling and marketing materials, negotiates contracts with distributors and clinical research sites, drafts responses to government audits/inspections and enforcement actions, prepares FDA device listings and state licensure applications, and conducts due diligence for mergers and acquisitions. Nicole also assists pharmacies, med spas, laboratories, physician groups, home health agencies, and residential care facilities with issues and questions related to licensure, physician oversight, prescriptions, compounding, telehealth, billing/coding, and the corporate practice of medicine.
Capacidades
Experiencia
- Researched state licensing requirements for wholesale distributors of Rx medical devices and OTC drugs.
- Advised device manufacturers on FDA labeling and packaging requirements for convenience kits and accessories.
- Requested orphan drug exemption from PDUFA program fees for small manufacturer of a rare disease drug.
- Prepared 510(k) submissions for remote monitoring devices and for software as a medical device.
- Advised foreign food producer on facility registration, prior notice of importation, and GRAS requirements.
- Researched co-development and cross-labeling requirements for a drug-biologic combination regimen.
- Conducted external audits evaluating compliance with the Anti-Kickback Statute, Stark law, and EKRA.
- Prepared health care regulatory disclosure schedules for acquisitions of laboratories and home health agencies.
- Submitted state licensing application for a residential care facility following a change in ownership.
- Drafted delegation and collaboration agreements for physician assistants and advanced practice nurses.
- Advised accountable care organizations on permissible incentive payments for Medicare beneficiaries.
- Counseled med spas on risks related to prescribing and administering compounded pharmaceuticals.
- Health Law Research Assistant, University of Georgia School of Law, 2020-2021
- Client Advocate, Tennessee Justice Center, 2018-2019
- Health Law Extern, American Bar Association, Center on Children and the Law, 2022
- Legal Extern, HHS Office of the General Counsel, Centers for Disease Control and Prevention, 2021
- Legal Intern, Atlanta Legal Aid Society, Health Law Partnership, 2021
- Policy Research Intern, ThinkTennessee, 2017
- Undergraduate Intern, Broward County State’s Attorney Office, 2017
Reconocimientos y Liderazgo
- Recognized, State Bar of Georgia, “Alan Rumph Memorial Health Law Fellowship,” 2021
- Member, Personal Care Products Council (PCPC)
- Member, District of Columbia Bar Association, 2022-Present
- Member, American Health Law Association, 2020-Present
Credenciales
-
J.D., cum laude, University of Georgia School of Law
- President, Health Law Society
- Member, Moot Court Team
- B.A., Vanderbilt University
- District of Columbia
- Portugués, Fluido
- Español, Proficient
- Francés, Conversacional