CookJ.Plain and simple advice for improving NDAs. Pharma Exec. Dec 1990;10(12):64–68.
2.
IND/NDA Rewrite Steering Committee position papers final report. Fed Reg.1979; Oct 12;44: 58919.
3.
Guideline for the format and content of clinical and statistical sections of new drug applications.Rockville MD: Center for Drug Evaluation and Research Office of Drug Evaluation I. July, 1988.
4.
Prescription Drug User Fee Act of 1992. PL 102-571 October 29, 1992.