FDA Adds Patent Declaration Forms For Innovators To Generic Final Rule
This article was originally published in The Tan Sheet
Executive Summary
Patent declaration forms must be used for Orange Book submission of patent information under FDA's generic reform final rule
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Patent information in currently pending NDAs may not fall under the jurisdiction of FDA's final rule on generic drugs
FDA Generics Rule: Relevance To Pending NDAs May Need Clarification – Troy
Patent information in currently pending NDAs may not fall under the jurisdiction of FDA's final rule on generic drugs