1. Statute—Section 505, Food, Drug, and Cosmetic Act (Public Law 75-717). 21 USC § 355(d). https://www.govinfo.gov/app/details/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec355
2. FDA Policy on Unapproved Drug Products: Past, Present, and Future
3. 21 CFR § 314.50 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.50); 21 CFR § 314.126 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.126)
4. Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012
5. Did the FDA break its own rules in approving the antibiotic Recarbrio?