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Issues in Clinical Trials

Regulatory issues in ALS clinical trials

Pages 36-41 | Published online: 10 Jul 2009

References

  • Guidance for Industry: Providing Clinical Evidence of Effective- ness for Human Drugs and Biological Products; Food and Drug Administration, Center for Biologics Evaluation and Research; www.fda.gov/cber/guidelines.htm
  • Weiss KD, Siegel JP. Issues in endpoint selection. In: Cato A, Sutton L, Cato A, editors. Clinical Drug Trials and Tribulations. New York: Marcel-Dekker, 2002: 79–92.
  • Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses. United States Code of Federal Regulations. 21 CFR 314 (Subpart H). April 1, 2003.
  • Fixed-combination prescription drugs for humans. United States Code of Federal Regulations. 21 CFR 300.50. April 1, 2003.

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