Works Cited

Expanding the Options: The Drug-Approval Process in the United States

Course #95001 - $30 -

  • Back to Course Home
  • Participation Instructions
    • Review the course material online or in print.
    • Complete the course evaluation.
    • Review your Transcript to view and print your Certificate of Completion. Your date of completion will be the date (Pacific Time) the course was electronically submitted for credit, with no exceptions. Partial credit is not available.

1. U.S. Food and Drug Administration. Fact Sheet: FDA at a Glance. Available at https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance. Last accessed July 7, 2023.

2. U.S. Food and Drug Administration. What We Do. Available at https://www.fda.gov/about-fda/what-we-do. Last accessed July 7, 2023.

3. National Center for Health Statistics. Health, United States, 2018. Available at https://www.cdc.gov/nchs/data/hus/hus18.pdf. Last accessed July 7, 2023.

4. Henry J. Kaiser Family Foundation. Number of Retail Prescription Drugs Filled at Pharmacies by Payer. Available at https://www.kff.org/health-costs/state-indicator/total-retail-rx-drugs. Last accessed July 7, 2023.

5. Kesselheim AS, Woloshin S, Eddings W, Franklin JM, Ross KM, Schwartz LM. Physicians' knowledge about FDA approval standards and perceptions of the "breakthrough therapy" designation. JAMA. 2016;315(14):1516-1518.

6. Center for Drug Evaluation and Research. Review Team Responsibilities. Available at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/review-team-responsibilities. Last accessed July 7, 2023.

7. U.S. Food and Drug Administration. Development and Approval Process: Drugs. Available at https://www.fda.gov/drugs/development-approval-process-drugs. Last accessed July 7, 2023.

8. U.S. Food and Drug Administration. FDA and Clinical Drug Trials: A Short History. Available at https://www.fda.gov/media/110437/download. Last accessed July 7, 2023.

9. U.S. Code of Federal Regulations. Title 21—Food and Drugs, Chapter I—Food and Drug Administration Department of Health and Human Services, Subchapter D—Drugs for Human Use, Part 314—Applications For FDA Approval To Market. Available at https://gov.ecfr.io/cgi-bin/text-idx?SID=fcf70feccc50ec11390054e40a58a5bb&mc=true&node=pt21.5.314&rgn=div5. Last accessed July 7, 2023.

10. U.S. Food and Drug Administration. Guidance Document: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-clinical-evidence-effectiveness-human-drug-and-biological-products. Last accessed July 7, 2023.

11. Daemmrich A. Pharmacovigilance and the missing denominator: the changing context of pharmaceutical risk mitigation. Pharm Hist. 2007;49(2):61-75.

12. The 87th U.S. Congress. Senate Report No. 1744, Part 2. Available at https://www.govinfo.gov/media/87-2num.pdf. Last accessed July 7, 2023.

13. U.S. Food and Drug Administration. Expanded Access Categories for Drugs (Including Biologics). Available at https://www.fda.gov/news-events/expanded-access/expanded-access-categories-drugs-including-biologics. Last accessed July 7, 2023.

14. U.S. Food and Drug Administration. FDA's Drug Review Process: Continued. Available at https://www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-continued. Last accessed July 7, 2023.

15. U.S. Food and Drug Administration. Step 1: Discovery and Development. Available at https://www.fda.gov/patients/drug-development-process/step-1-discovery-and-development. Last accessed July 7, 2023.

16. U.S. Food and Drug Administration. Drug Development and Review Definitions. Available at https://www.fda.gov/drugs/investigational-new-drug-ind-application/drug-development-and-review-definitions. Last accessed July 7, 2023.

17. U.S. Food and Drug Administration. Investigational New Drug (IND) Application. Available at https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application. Last accessed July 7, 2023.

18. U.S. Food and Drug Administration. Step 3: Clinical Research. Available at https://www.fda.gov/patients/drug-development-process/step-3-clinical-research. Last accessed July 7, 2023.

19. U.S. Food and Drug Administration. Advisory Committees: Critical to the FDA's Product Review Process. Available at https://www.fda.gov/drugs/drug-information-consumers/advisory-committees-critical-fdas-product-review-process. Last accessed July 7, 2023.

20. Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987–2014: cohort study. BMJ. 2015;351:h4633.

21. U.S. Food and Drug Administration. Guidance Document: Expedited Programs for Serious Conditions—Drugs and Biologics. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics. Last accessed July 7, 2023.

22. U.S. Food and Drug Administration. Novel Drug Approvals for 2019. Available at https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019. Last accessed June 8, 2020.

23. U.S. Food and Drug Administration. Novel Drug Approvals for 2022. Available at https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022. Last accessed July 7, 2023.

24. U.S. Food and Drug Administration. Accelerated Approval. Available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval. Last accessed July 7, 2023.

25. Centers for Disease Control and Prevention. Update: mortality attributable to HIV infection among persons aged 25–44 Years—United States, 1991 and 1992. MMWR. 1993;42(45);869-872.

26. 26. U.S. Food and Drug Administration. FDA's Comprehensive Response to HIV. Available at https://www.fda.gov/news-events/fda-voices/fdas-comprehensive-response-hiv-part-i. Last accessed July 7, 2023.

27. U.S. Food and Drug Administration. Food and Drug Administration Safety and Innovation Act (FDASIA). Available at https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-administration-safety-and-innovation-act-fdasia. Last accessed July 7, 2023.

28. Federal Food, Drug, and Cosmetic Act. Section 355e: Pharmaceutical Security. Available at https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355e&num=0&edition=prelim. Last accessed July 7, 2023.

29. Federal Food, Drug, and Cosmetic Act. Section 356: Expedited Approval of Drugs for Serious or Life-Threatening Diseases or Conditions. Available at https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356&num=0&edition= prelim. Last accessed July 7, 2023.

30. U.S. Food and Drug Administration. Priority Review. Available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Last accessed July 7, 2023.

31. U.S. Food and Drug Administration. Postmarketing Requirements and Commitments: Reports. Available at https://www.fda.gov/drugs/postmarket-requirements-and-commitments/postmarketing-requirements-and-commitments-reports. Last accessed July 7, 2023.

32. U.S. Food and Drug Administration. Expanded Access. Available at https://www.fda.gov/news-events/public-health-focus/expanded-access. Last accessed July 7, 2023.

33. U.S. Food and Drug Administration. FDA Transparency Initiative Overview. Available at https://www.fda.gov/about-fda/transparency/transparency-initiative. Last accessed June 8, 2020.

34. 34.U.S. Food and Drug Administration. Transcript: FAERS. Available at https://www.fda.gov/drugs/information-healthcare-professionals-drugs/transcript-faers. Last accessed July 7, 2023.

35. Greene JA, Podolsky SH. Reform, regulation, and pharmaceuticals: the Kefauver-Harris Amendments at 50. N Engl J Med. 2012;367(16):1481-1483.

36. U.S. Food and Drug Administration. Frequently Asked Questions: Breakthrough Therapies. Available at https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies. Last accessed July 7, 2023.

37. National Coordinating Council for Medication Error Reporting and Prevention. Available at https://www.nccmerp.org/about-medication-errors. Last accessed July 7, 2023.

38. U.S. Food and Drug Administration. Rare Diseases Program. Available at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/rare-diseases-program. Last accessed July 7, 2023.

39. U.S. Food and Drug Administration. Office of Orphan Products Development. Available at https://www.fda.gov/about-fda/office-clinical-policy-and-programs/office-orphan-products-development. Last accessed July 7, 2023.

40. U.S. Food and Drug Administration. CDER Patient-Focused Drug Development. Available at https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development. Last accessed July 7, 2023.

41. U.S. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act (FD&C Act). Available at https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act. Last accessed July 7, 2023.

42. U.S. Food and Drug Administration. Drug Approval: Bringing a New Drug to the Market. Available at https://www.fda.gov/media/94428/download. Last accessed July 7, 2023.

  • Back to Course Home
  • Participation Instructions
    • Review the course material online or in print.
    • Complete the course evaluation.
    • Review your Transcript to view and print your Certificate of Completion. Your date of completion will be the date (Pacific Time) the course was electronically submitted for credit, with no exceptions. Partial credit is not available.