Suite 1100 - East Tower
Washington, District Of Columbia 20005
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. 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.
Prior to beginning her legal career, Celeste was a registered nurse practicing in the areas of internal medicine, infectious diseases and oncology. In her career at MedImmune, she developed the pharmacovigilence program, participated in the preparation and submission of biologic licensing applications and launch of new products. As a registered nurse with experience in industry, Celeste has a strong understanding of the FDA and health care regulatory issues affecting biologic, pharmaceutical and medical device manufacturers and distributors.
|Areas of Practice||1) Health Care, 2) FDA Regulatory Compliance, 3) Health Care Fraud and Abuse, 4) HIPAA and Health Privacy Laws, 5) Corporate & Securities, 6) Life Sciences Transactions & Regulatory, 7) Life Sciences Transactions, 8) Life Sciences Health Industry Group and 9) Data Privacy|
|Law School||University of Maryland School of Law, J.D., 2004|
|Education||Winchester and Basingstoke School of Nursing, Engl, 1984|
|Bar Member / Association||District of Columbia Bar Association, Maryland State Bar Association|
|Most recent firm||Reed Smith LLP|
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