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Are biologics eligible for pediatric exclusivity?

April 26, 2017biologics eligible exclusivity pediatric

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Are biologics eligible for pediatric exclusivity?

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A8. No. Only drug products subject to section 505 of the Food, Drug, and Cosmetic Act are eligible for pediatric exclusivity. CBER, however, regulates a small number of drug products that are subject to section 505. These products would be eligible for pediatric exclusivity if the other statutory conditions are met. Biological products that are subject to the Public Health Service Act are not eligible for pediatric exclusivity, even if they have orphan exclusivity or other patent protection.