Legal Issues in Companion Diagnostics

On January 23rd, members of the Hogan Lovells Global Regulatory Health Care and FDA practice group will provide an in-depth presentation focused on Companion Diagnostics (CDx). The program will cover CDx vs Laboratory Developed Tests, some history of FDA regulation in this area, the FDA regulatory requirements for approval of a CDx, and the rules governing advertising and promotion for these offerings. It also will cover pharmaceutical collaboration agreements, including from the perspective of pharmaceutical companies, address regulatory and reimbursement considerations in establishing these arrangements, and an introduction to the regulation of CDx and pharmaceutical collaborations in Europe.

CLE credit is pending approval in New York, California, Texas, and North Carolina.

To register your interest, please contact Kenneth Townsend at (502) 915-0250 or [email protected].

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