Promotion Under Pressure: FDA Advertising and Promotion Risks for Life Sciences Companies

Event Details

Before promotional materials reach their intended audience, it is critical for life sciences companies to consider whether their approval processes adequately identify problematic claims.

On November 3, please join AGG Food & Drug attorneys Alan Minsk and Laura LaBrie for a webinar discussing current FDA enforcement trends in pharmaceutical and medical device promotion. Alan and Laura will explore issues arising in medical, legal, and regulatory (“MLR”) and promotional review committee (“PRC”) processes, identify opportunities to reduce promotional risk, and examine legal considerations beyond FDA requirements to help life sciences companies strengthen their compliance measures.

What You Will Learn

• Where FDA is focusing its advertising and promotion enforcement efforts and which practices may attract greater scrutiny.
• How to identify weaknesses in MLR and PRC processes that could allow problematic promotional claims or materials to receive approval.
• What steps companies can take to improve promotional review, address compliance gaps, and reduce the likelihood of enforcement concerns.
• How non-FDA legal requirements can affect pharmaceutical and medical device advertising and promotion.

Who Should Attend

• In-house counsel supporting pharmaceutical, biotechnology, medical device, and other life sciences companies
• Regulatory affairs and regulatory compliance professionals
• Medical, legal, and regulatory review committee members
• Marketing, advertising, communications, and commercial professionals involved in developing or approving promotional materials
• Compliance and risk management professionals responsible for advertising and promotional practices

There will be an opportunity for Q&A at the end of this webinar.

Credits: 1 hour of CLE credit is pending approval by the State Bar of Georgia.