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Monday, June 27 • 8:30am - 9:45am
#108: Drug/In Vitro Diagnostic Device Advertising and Promotion: Unapproved Combination Product or Awareness?

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-526-L01-P; CME 1.25; IACET 1.25; RN 1.25

In vitro diagnostic devices are important tools intended for use in the diagnosis of disease or other conditions, including a determination of the state of health. Based on a diagnosis, it seems reasonable for a company to recommend an appropriate prescription drug treatment. This session reviews the basics of advertising and promotion for devices and prescription drugs in the context of intended use and approved indications. Taking the substantial evidence requirements and recent 1st Amendment challenges into consideration, the panelists will provide a systematic assessment of scenarios when company may or may not co-promote or recommend a prescription treatment based on a diagnostic outcome.

Learning Objectives

Identify valuable insights into the regulatory and legal boundaries of advertising and promotion of a device with a prescription drug when these tactics go beyond the approved intended use/indication, and when this may be viewed as an unapproved new combination device/drug product.


Kimberly Belsky, MS


Alan G. Minsk, JD

Minnie Baylor-Henry, JD, RPh

avatar for Kimberly Belsky

Kimberly Belsky

Senior Director, Regulatory Affairs, Regulatory Intelligence, Mallinckrodt Pharmaceuticals
Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals... Read More →

avatar for Minnie Baylor-Henry

Minnie Baylor-Henry

President, B-Henry & Associates
President of B-Henry & Associates, a consulting firm focused on providing regulatory and compliance strategy services to life sciences companies. Prior to assuming her current role in early 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s... Read More →
avatar for Alan Minsk

Alan Minsk

Partner, Head of Food and Drug Team, Arnall Golden Gregory LLP
Alan G. Minsk is a partner in the Food and Drug and Government and Regulatory Practices. Mr. Minsk was recognized in chambers USA America's Leading Lawyers for Life Sciences, Regulatory/Compliance and was selected for inclusion in the International Who’s Who of Life Sciences Lawyers... Read More →

Monday June 27, 2016 8:30am - 9:45am EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv-Mkting, Forum