1. Food and Drug Administration. Guidance for Industry: Fast Track Drug Development Programs—designation, development, and application review. Rockville, MD: Food & Drug Administration; September 1998.
2. Another view on industry response to fast track program. US Regulatory Reporter. 1998 Sep;15(3):1–2.
3. Drug industry has not yet embraced FDAMA’s “Fast Track” program. US Regulatory Reporter. 1998 Aug; 15(2):1–3.
4. An interview with Director of the Division of Cardio-renal Drug Products Raymond Lipicky, M.D. US Regulatory Reporter. 1999 Oct;16(4):3–7.
5. PhRMA proposals for fast-track products. Pharma Marketletter. 1998 Apr 27;25(7):13.