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Info Collection Extension for Drug Patent Listings
05/17/2019
 

Federal Register notice: FDA is seeking comments on an information collection extension for “Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements” (OMB Control Number 0910-0513). The federal Food, Drug, and Cosmetic Act requires all NDA applicants to file, as part of the NDA, the patent number and the expiration date of any patent that claims the drug for which the applicant submitted the application or that claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. To view the notice, click here.


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