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9 Mar 2020, 1:21 pm
FDA and FTC Approaches to Help Ensure Truthful and Non‐misleading Advertising and Promotional Communications Lowell Schiller, Principal Associate Commissioner for Policy, FDA: have seen troubling communications suggesting biosimilars are less safe/less effective than reference products or that there may be clinically meaningful differences b/t them when biosimilars can’t be approved unless there are no clinically meaningful differences. [read post]