Analysis of the first ten years of FDA’s rare pediatric disease priority review voucher program: designations, diseases, and drug development

Table 4 Summary of awarded RPD priority review vouchers, 2014–2022 (n = 38)

	Number of RPD priority review vouchers awarded	Therapeutic area (s)
2014	1	Metabolism (1)
2015	5	Metabolism (4); Oncology (1)
2016	2	Neurology (2)
2017	5	Neurology (2); Metabolism (1); Oncology (1); Ophthalmology (1)
2018	5	Immunology (2); Metabolism (1); Neurology (1); Pulmonary (1)
2019	3	Neurology (2); Pulmonary (1)
2020	7	Metabolism (3); Neurology (3); Oncology (1)
2021	6	Gastroenterology (1); Metabolism (1); Neurology (1); Ophthalmology (1); Orthopedics (1); Pulmonary (1)
2022	4	Neurology (2); Hematology (1); Metabolism (1)

Per Sect. 505 (b)(1) of the FD&C Act or Sect. 351 of the Public Health Service (PHS) Act, the PRV can be redeemed for a priority review instead of a standard review for another drug or biologic submitted for FDA approval after the date of approval of the rare pediatric disease product

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