Bradley Merrill Thompson, Member of the Firm, will co-present “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 will review 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 will address how industry is currently handling reporting in the interim.
For more information and to register, contact Lauren M. Power, (301) 770 2920 x278, firstname.lastname@example.org. Or visit http://www.raps.org/PersonifyEbusiness/Home/tabid/1556/Default.aspx.