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Patent and Exclusivity Panel Discussion: Proposals to Improve FDA's Decision-making and Communication Practices Brian R. McCormick Brian. McCormick@TevaPharm.com (215) 2936636 October 26, 20162016

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What is patent and exclusivity panel?

Patent and exclusivity panel is a form filed with regulatory authorities to report information about patents and exclusivity rights related to a drug.

Who is required to file patent and exclusivity panel?

The manufacturer or sponsor of a drug is required to file patent and exclusivity panel.

How to fill out patent and exclusivity panel?

To fill out patent and exclusivity panel, the manufacturer or sponsor must provide information about any patents or exclusivity rights related to the drug.

What is the purpose of patent and exclusivity panel?

The purpose of patent and exclusivity panel is to provide transparency and information about the intellectual property rights related to a drug.

What information must be reported on patent and exclusivity panel?

The patent and exclusivity panel must include information about any patents or exclusivity rights related to the drug, including expiration dates.

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