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Patent Applications › Regulatory Requirements › Food and Drug Administration (FDA)

Fish & Richardson

From Inspiration to Blockbuster: A MedTech Q&A

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The medical technology (“medtech”) innovation process is marked by several key stages. The journey typically begins with ideation, the phase at which inspiration strikes and ideas are generated. From there, the process moves...more

Offit Kurman

Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into...

Offit Kurman on

The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more

Venable LLP

Spotlight On: Biosimilar Litigations - July 2025

Venable LLP on

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

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