Jayne P. Bultena
Of Counsel
 

 
T: 703-626-2542
F: 202-557-3836
 
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EDUCATION:

BS, University of South Dakota, 1987, magna cum laude

JD, Harvard Law School, 1991

 
 

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Jayne Bultena is a Bergeson & Campbell, P.C. (B&C®) attorney who focuses on food, drug, medical device, and consumer product law and regulation. Having been an associate and partner at premier, nationally known law firms, she has over 20 years of experience in food and drug regulatory matters, including approval, labeling, compliance, and promotion of consumer health care products, biologics, diagnostics, food, and dietary supplements.

Ms. Bultena has counseled and represented clients across the entire spectrum of industries under the regulatory auspices of the U.S. Food and Drug Administration (FDA). In this regard, she has worked with businesses from start-ups to Fortune 100 companies, products from prescription drugs to dietary supplements, and tasks from complicated compliance audits to management of press relations.

Representative Engagements:

  • Worked with a Fortune 100 company to audit and proactively change its internal practices and standards for awarding grants, conducting CME, and selecting and training key opinion leaders.
  • Worked with a consumer product company and the FDA to identify and recall a major consumer over-the-counter (OTC) drug that had been diverted and sold into the gray market with counterfeit packaging.
  • Worked with start-up companies to assess the regulatory requirements for novel, new products, including in vitro diagnostics and research-use-only products.

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