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21 U.S.C. § 355d
Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
21 U.S.C. § 360n–1
Priority review for qualified infectious disease products
Priority review for qualified infectious disease products
21 U.S.C. § 355c
Research into pediatric uses for drugs and biological products
Research into pediatric uses for drugs and biological products
21 U.S.C. § 355f
Extension of exclusivity period for new qualified infectious disease products
Extension of exclusivity period for new qualified infectious disease products
21 U.S.C. § 355h
Regulation of certain nonprescription drugs that are marketed without an approved drug application
Regulation of certain nonprescription drugs that are marketed without an approved drug application
21 U.S.C. § 355–1
Risk evaluation and mitigation strategies
Risk evaluation and mitigation strategies