1. US FDA Critical Path Initiative: Transforming the way FDA-regulated products are developed, evaluated, and manufactured. Challenges and Opportunities Report - March 2004. https://www.fda.gov/science-research/science-and-research-special-topics/critical-path-initiative (Accessed May 11, 2020).
2. Hussain, A.S., Gurvich, V.J., and Morris, K., 2019. Pharmaceutical “new prior knowledge”: twenty-first century assurance of therapeutic equivalence. AAPS Pharm Sci Tech, 20(3): 140 (2019). https://doi.org/10.1208/s12249-019-1347-6 (Accessed May 11, 2020).
3. S.3537 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020. Introduced 03/19/2020. Moving American Pharmaceutical Production Out of China for the Health and Safety of Americans. https://www.congress.gov/bill/116th-congress/senate-bill/3537/text ().
4. H.R.6670 - Prescription for American Drug Independence Act of 2020. To provide for an exploration of strategies to increase domestic manufacturing and diversify the supply chain of critical drugs, and for other purposes. Introduced 05/01/2020. https://www.govtrack.us/congress/bills/116/hr6670/text (Accessed May 11, 2020).
5. FDA reports more shortages of drugs used to put COVID-19 patients on ventilators. https://www.raps.org/news-and-articles/news-articles/2020/4/fda-reports-more-shortages-of-drugs-used-to-put-co (Accessed May 11, 2020).