To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA
FDA Law Blog
SEPTEMBER 19, 2023
Thus, “FTC intends to use its full legal authority” to take action “against companies and individuals that improperly list patents in the Orange Book that do not meet the statutory listing criteria.” And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue.
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