Jayne P. Bultena
Jayne’s practice focuses on food and drug regulatory and legislative matters, with particular emphasis on biotechnology, pharmaceutical and consumer health care products. Jayne represents clients on a wide range of issues involving the U.S. Food and Drug Administration (FDA). She routinely counsels clients on the development of claims, labeling, and promotional materials for prescription and OTC drugs, dietary supplements, conventional and functional foods, and cosmetics.
Jayne also advises clients on all aspects of drug product approvals, including the development of product life-cycle management strategies and the process of switching drugs from prescription to over-the-counter (OTC) status. Her practice includes creating novel marketing plans to address policy and regulatory concerns, preparing clients for advisory committee presentations, and conducting internal compliance audits and training. She has significant experience managing compliance crises and promotional violations, including FDA inspections, responding to deficiency and warning letters, conducting recalls, and coordinating press and media relations.
In addition to her work on FDA issues, Jayne represents clients before other agencies that regulate the sale of consumer products, including the U.S. Consumer Product Safety Commission (CPSC) and the U.S. Federal Trade Commission (FTC).
Bars and Court Admissions
- District of Columbia
- Pennsylvania
- South Dakota
SPEECHES AND CONFERENCES
- Speaker, “FDA 101: Importing Food, Drugs and Devices,” American Conference Institute’s 4th Annual Advanced Forum on Import Compliance, Washington, DC, September 22-24, 2008
- Speaker, "The Basics: Understanding and Working with the FDA - Jurisdictions, Functions, Organizations, and Operations," American Conference Institute's FDA Boot Camp, San Francisco, CA, May 29-30, 2008
publications
- FDA’s New Drug Labeling Format: Opportunity and Challenge, NEXT GENERATION PHARMACEUTICAL, GDS International