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Can an applicant obtain exclusivity by submitting an analysis of the literature in response to a Written Request?

April 26, 2017analysis applicant exclusivity Literature obtain request Response written

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Can an applicant obtain exclusivity by submitting an analysis of the literature in response to a Written Request?

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A5. Simply compiling the literature on pediatric use of a drug in a given indication will not qualify an applicant for pediatric exclusivity. The generous incentives were made available to stimulate performance of studies necessary to provide useful information on drug use in children.