A Pink Sheet article published March 25 examined how corporate communications can create pre-approval promotion enforcement risks for biopharmaceutical companies. Comments from life sciences partner Kellie Combs (Washington, D.C.) are included from a recent panel discussion at the Drug Information Association’s Advertising and Promotion Regulatory Affairs Conference.
Ms. Combs explains that statements made by clinical study investigators prior to U.S. Food and Drug Administration approval of a product can pose risk for the company that sponsored the study. As a result, companies should take steps to ensure that investigators are not making promotional claims about the safety or effectiveness of the product.
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