Celeste advises clients on FDA and health care regulatory, compliance and enforcement matters. Celeste specializes in advising clients on FDA regulatory and transactional issues related to pre-clinical and clinical trials; marketing approval; product labeling; manufacturing and distribution; advertising and promotion; pharmacovigilence, biospecimens, and FDA inspections and enforcement actions. In particular, Celeste has significant experience with manufacturing issues and quality agreements. Celeste also advises clients on a broad range of health care regulatory matters, including: Medicare coverage of routine costs and medical devices in clinical trials, HIPAA, and state regulation of manufacturers, distributors and health care providers.
- University of Maryland School of Law, 2004, J.D.
- University of Maryland, 2000, B.S., Nursing, School of Nursing
- Winchester and Basingstoke School of Nursing, 1984, Registered General Nurse Training and Certification; Hampshire, England
- Distrito de Columbia
- American Health Lawyers Association
- Food & Drug Law Institute
- Maryland Bar Association
- District of Columbia Bar Association
- Registered Nurse, Maryland (Inactive status)
- Member of the Professional Register of the United Kingdom Central Council Nursing, Midwifery, and Health Visiting, Registered Nurse, London, England (Inactive status)
Premios y reconocimientos
- Ranked in Chambers USA for District of Columbia Healthcare: Pharmaceutical/Medical Products Regulatory, 2021-2022
- Selected through peer review for inclusion in The Best Lawyers in America© for FDA Law, 2023