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 Abt 6001 Form 2013

2013-2025 Form

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thank you for the kind introduction for the next half hour I'll be presenting an overview of fda's patent listing process here are a few learning objectives for my presentation first I will provide an overview of pan listing requirements second I'll explain the submission process for listing patent in the orange book third I'll explain some key aspects of the current form FDA 3542 an area that you should pay attention to when completing the form so what are the statutory and Regulatory backgrounds that govern patent listings patents are granted by the US patent and trademark offers at any time in the life of a Jer NDA applicants are required to file patent information with their application under Section file 5 B1 and 505 C2 of the foot drug and cosmetic act for each patent that claims the drug or method of using their drug information such as drug substance or active ingredient patterns drug product or formulation and composition patterns and lastly met

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