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Salminen WF et al. Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway. Drug Discov Today. 2019;24(1):46-56.

Camp KM et al. Nutritional treatment for inborn errors of metabolism: indications, regulations, and availability of medical foods and dietary supplements using phenylketonuria as an example. Mol Genet Metab. 2012;107(1-2):3-9.

Das AM. Pharmacotherapy of inborn errors of metabolism illustrating challenges in orphan diseases. J Pharmacol Toxicol Methods. 2016;81:9-14.

Gambello MJ et al. Current strategies for the treatment of inborn errors of metabolism. J Genet Genomics. 2018;45(2):61-70.

Kakkis ED et al. Accessing the accelerated approval pathway for rare disease therapeutics. Nat Biotechnol. 2016;34(4):380-383.

Keller AS et al. Replacement therapies in metabolic disease. Curr Pharm Biotechnol. 2018;19(5):382-399.

Levenson D. Advocates call for long-term extension of the FDA’s rare pediatric disease priority review program: federal voucher program considered instrumental in shortening drug review, approval period. Am J Med Genet A. 2017;173(1):7-8.

Ridley DB et al. The commercial market for priority review vouchers. Health Aff (Millwood). 2016;35(5):776-783.

Salminen WF et al. Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway. Drug Discov Today. 2019;24(1):46-56.