Experience

Bergeson & Campbell, P.C.

• United States
• Law Practice
• 1 - 100 Employee

• Of Counsel

  • 2011 - Present

  Jayne Bultena focuses on food, drug, medical device, and consumer product matters and regulation. Ms. Bultena has over 20 years of experience in food and drug regulatory matters, including approval, labeling, compliance, and promotion of pharmaceutical and consumer health care products, biologics, diagnostics, medical devices, food, and dietary supplements. Ms. Bultena has counseled 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. Ms. Bultena has counseled a wide variety of organizations as well as venture capital investors on issues including: • Managing compliance risks and promotional violations, including FDA inspections. • Responding to deficiencies and warning letters, conducting recalls, and coordinating press and media relations. • Development of claims, labeling, and promotional materials, including websites, social networking, and clinical medical education (CME). • Petitioning the FDA on changes in patent restoration terms, barring use of volunteers for certain clinical testing, supporting regulation of tobacco products, and clarifying orphan drug designations. • Bringing unique food, dietary supplement, and cosmetic products to market through appropriate regulatory pathways. In addition to working on behalf of clients before the FDA, Ms. Bultena has represented clients before the Consumer Product Safety Commission (CPSC) and the Federal Trade Commission (FTC).



The Acta Group

• United States
• Chemical Manufacturing
• 1 - 100 Employee

• Of Counsel

  • 2011 - Present



Foley Hoag LLP

• Law Practice
• 500 - 600 Employee

• Partner

  • 2007 - 2009



Hogan & Hartson

• Law Practice
• 200 - 300 Employee

• Partner

  • 2003 - 2007



Fox, Bennett & Turner

• Associate, Partner

  • 1991 - 2003