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What is form fda 3542 patent?
Form FDA 3542 is used to report patent information for certain drug products to the Food and Drug Administration (FDA).
Who is required to file form fda 3542 patent?
Manufacturers or sponsors of drug products approved under the Federal Food, Drug, and Cosmetic Act are required to file Form FDA 3542.
How to fill out form fda 3542 patent?
Form FDA 3542 can be filled out electronically on the FDA's Electronic Submissions Gateway (ESG) or manually by completing the form and submitting it to the FDA.
What is the purpose of form fda 3542 patent?
The purpose of Form FDA 3542 is to provide the FDA with patent information related to drug products to ensure compliance with applicable laws and regulations.
What information must be reported on form fda 3542 patent?
Form FDA 3542 requires the reporting of patent information including the name and address of the patent holder, patent number, expiration date, and whether the patent is listed in the Orange Book.
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