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En Fuel 2019 Sponsorship Opportunities Presenting Sponsor$10,000+ Exclusivity as the only presenting sponsor within your field of business Sponsors corporate name with Presented by appears with event
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What is exclusivity as form only?
Exclusivity as form only is a type of application that allows for a limited period of exclusivity for a specific drug product without the need for submitting certain parts of the application.
Who is required to file exclusivity as form only?
The applicant who wants to seek exclusivity as form only for their drug product is required to file it.
How to fill out exclusivity as form only?
To fill out exclusivity as form only, the applicant needs to provide information about the drug product, including evidence of bioequivalence, safety, and efficacy.
What is the purpose of exclusivity as form only?
The purpose of exclusivity as form only is to provide a streamlined pathway for certain drug products to obtain exclusivity without the burden of submitting certain parts of the application.
What information must be reported on exclusivity as form only?
The information required to be reported on exclusivity as form only includes data on bioequivalence, safety, and efficacy of the drug product.
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