Epstein Becker Green attorney Bradley Merrill Thompson spoke on the following three topics:
1) Cross Labeling—Fact or Fiction?
In 2005, the Office of Combination Products (OCP) held a conference on the cross labeling “problem.” In 2008, OCP issued guidance on New Contrast Imaging Indications. This session examined whether cross labeling really poses a significant problem and what OCP’s guidance suggests about the future of cross labeling. Attendees learned how separately marketed products might be considered combination products through labeling, when cross labeling is and isn’t required, some creative possibilities and whether it can ever work to your advantage.
2) Shedding Light on New Rules for Adverse Event Reporting
In recent years, the combination products industry has grappled with how to address conflicting rules for reporting adverse events. FDA has published a concept paper on a proposed rule which is anticipated to be released by FDA before 2010. This session reviewed the concept paper, the Combination Product Coalitions (CPC) perspectives on the paper and the industry’s reaction including implications for drug and medical device companies that market combination products. It addressed how industry is currently handling reporting in the interim. Mr. Thompson was the Session Leader.
3) OCP Executive Staff Briefing
Most experts predict that combination products will continue to be a significant growth area for the healthcare industry. This session featured leadership from FDA’s Office of Combination Products (OCP) discussing priorities and current policy initiatives, key regulations and guidance documents. Attendees benefited from the insight and perspectives of the Combination Products Coalition, a leading advocacy group for policy on regulatory issues affecting combination products.
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